| HS Code | 605048 |
| Product Name | Hydrophilic Ointment RQ-100 |
| Product Code | RQ-100 |
| Product Category | Topical ointment base |
| Product Type | Water-miscible hydrophilic ointment |
| Physical Form | Semi-solid ointment |
| Appearance | White to off-white, smooth, homogeneous |
| Odor | Mild characteristic odor |
| Solubility | Dispersible/miscible with water; washable from skin |
| Ph | Typically near neutral to slightly acidic in aqueous dispersion |
| Primary Function | Ointment base and carrier for topical preparations |
| Application Route | Topical use only |
| Composition Type | Hydrophilic ointment base with water-miscible emulsifying and emollient components |
| Storage Conditions | Store at controlled room temperature; protect from freezing and excessive heat |
| Packaging | Supplied in jars, pails, or drums according to supplier |
| Shelf Life | Refer to manufacturer label and batch certificate |
As an accredited Hydrophilic Ointment RQ-100 factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Hydrophilic Ointment RQ-100 is packaged in a 100 g white plastic jar, sealed and labeled, within a protective carton. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Hydrophilic Ointment RQ-100 in sealed drums, properly secured, labeled, and stowed for safe transport. |
| Shipping | Hydrophilic Ointment RQ-100 should be shipped in securely sealed, properly labeled containers at ambient temperature, protected from freezing, moisture, and contamination. Handle as non-hazardous unless the SDS or local regulations indicate otherwise. Keep packages upright, avoid damage, use secondary containment where appropriate, and include required shipping documentation. |
| Storage | Store Hydrophilic Ointment RQ-100 in a tightly closed container in a cool, dry, well-ventilated area, protected from light and moisture. Keep away from ignition sources and incompatible chemicals. Maintain the manufacturer-recommended temperature, typically 15–25°C, and do not freeze. Avoid excessive heat, sparks, and open flames. Inspect containers regularly for damage or leakage. Keep out of reach of children. |
| Shelf Life | Hydrophilic Ointment RQ-100 has a shelf life of 24 months when stored cool, dry, and protected from light and moisture. |
Early-phase dermatological clinical trials require a placebo that matches the active formulation in visual appearance, rub-in profile, odor, and occlusivity without contributing a pharmacologically active compound. RQ-100 is used as the continuous phase of oil-in-water placebo emulsions at 90–100 wt% and as the vehicle for active arms at 80–95 wt%, with model actives such as hydrocortisone 0.1–1.0 wt% or calcipotriene 0.1 wt%. The primary process restriction is not chemical compatibility but air entrapment during high-shear homogenization. A vacuum planetary mixer with a swept-wall agitator at 25–40 rpm and a rotor-stator homogenizer at 1,500–3,000 rpm is operated under -0.85 bar to reduce entrained air below 0.5 vol%. In-process density is checked by specific gravity per USP <841> because air inclusions lower the delivered dose per gram and alter the mechanical rub-in profile. Cooling below 30°C before all stearyl alcohol has fully dispersed produces a grainy texture that fails visual release inspection. In vitro release testing per USP <1724> is applied to compare active and placebo batches using a vertical diffusion cell with a 0.45 µm polysulfone membrane and receptor medium consisting of pH 7.4 phosphate-buffered saline with 0.5% sodium dodecyl sulfate at 32°C and 600 rpm. Published RQ-100-specific release rate limits are limited; regulatory acceptance is based on comparative profile similarity to a reference lot rather than an absolute flux threshold. A documented failure mode in phase I material manufacture is phase separation when the homogenizer is operated beyond 30 minutes without jacket cooling, which raises the bulk temperature above 45°C and destabilizes the lamellar structure of the water phase.
Hydrophilic Ointment RQ-100 is applied to periwound skin and peristomal tissue under healthcare supervision only when the epidermis remains intact. The base is not sterile and must not be placed into open wound beds. In ostomy care, RQ-100 is combined with skin protectant actives such as zinc oxide 5–15 wt% or dimethicone 1–5 wt%, with RQ-100 at 80–90 wt% of the formulation. Low-shear planetary mixing at 50–80 rpm is preferred because high-shear dispersion of zinc oxide increases wetted particle surface area and can shift the water phase pH to 7.5–8.5, which risks emulsion destabilization. The terminal packaging is a 50–100 g tube with an orifice diameter of 3–5 mm to prevent excessive film disruption during application. Microbial testing per USP <61> and USP <62> is mandatory for non-sterile topical preparations; total aerobic microbial count must remain below 100 CFU/g, and absence of Pseudomonas aeruginosa and Staphylococcus aureus must be confirmed. If the product is labeled as an OTC skin protectant, active ingredient combinations must conform to 21 CFR 347.10. White petrolatum, already present in RQ-100, is permitted only at 30–100 wt% of the finished product, so dilution with additional excipients must not reduce the petrolatum content below that monograph threshold. In healthcare facility practice, batch-to-batch handling variance is commonly observed when the aqueous phase evaporates from open ward containers; the resulting increase in viscosity alters the spreadability index measured by USP <1724> and necessitates a rework or discard decision.
Perineal and peristomal skin present a compromised barrier with elevated transepidermal water loss and maceration risk when occlusive anhydrous petroleums are used continuously. RQ-100 reduces the occlusive burden because its continuous water phase permits some water vapor exchange while retaining lipophilic components at the stratum corneum surface. The base is levigated with zinc oxide in amounts up to 20 wt% for maceration-prone folds, but no preservative-free claim is permitted because RQ-100 contains parabens unless the certificate of analysis specifically states otherwise. Stability testing at 40°C/75% RH for 3 months per ICH Q1A R2 is typically used to justify the clinical supply period. Published data on RQ-100-specific skin hydration indices is limited; comparator emollient studies generally measure corneometry readings against an untreated site and report relative improvement after 14 days of twice-daily application, but absolute values vary with anatomical site and ambient humidity.
RQ-100 is incorporated into leave-on cosmetic emollients for xerotic and winter-dry skin at loadings of 85–95 wt%. Humectants such as glycerin 5–10 wt% and skin conditioning actives such as urea 5–10 wt% are added after the base has been warmed to 40–50°C. Low-shear side-scraping agitation at 25–50 rpm is maintained during cooling at 1°C/min to prevent viscosity build-up at the vessel wall and to avoid air incorporation. Cosmetic compliance falls under Regulation (EC) No 1223/2009 Annex II–VI, and REACH Annex VII chemical safety assessment applies to substances imported above 1 metric tonne/year. Preservative efficacy is evaluated according to ISO 11930 using a category 2 product designation; the acceptance criterion requires a logarithmic reduction in bacterial and fungal challenge organisms within specified contact times. The terminal packaging may be a 50–200 mL jar or airless pump designed to deliver 0.5–1.0 mL per actuation. Petrolatum in RQ-100 is qualified under CAS 8009-03-8 and must meet the purity profile of Ph. Eur. 1410 or USP for mineral hydrocarbons. A documented formulation pitfall in cosmetic scale-up is over-homogenization of the aqueous phase above 3,000 rpm, which generates localized shear heating above 45°C and breaks the lamellar network, yielding a thin, pituitous texture that fails rheological acceptance.
Veterinary dermatology practice uses RQ-100 as a washable vehicle for compounded topical and transdermal preparations intended for companion animals. The regulatory frame is FDA CPG 608.400, which permits animal drug compounding when an approved animal or human drug cannot meet the individual patient need. Typical API loadings in RQ-100 include tacrolimus 0.1 wt%, dexamethasone 0.1 wt%, and mupirocin 2.0 wt%, with the base at 97–99.9 wt%. Geared electronic mortars and pestles are used for batches under 1 kg, while larger batches are processed in a 5 kg planetary mixer with a PTFE scraper at 30 rpm. Dermal retention on hair-bearing canine or equine skin is influenced by the water phase fraction; published RQ-100-specific data in veterinary species is limited, and practitioners often add white petrolatum 5–10 wt% to increase the residence time on hair shafts. The compounded product is dispensed in oral syringes with 1 mL graduations to minimize contamination from repeated spatula contact. Documentation of individual patient need and species-specific dosing is required under CPG 608.400, and the water-containing preparation is assigned a conservative beyond-use date until site-specific stability data are generated.
In vitro permeation testing is performed to compare the release of a model active from RQ-100 against a reference formulation or to qualify the base as a vehicle control. The procedure follows OECD TG 428 and USP <1724>, with 200–300 mg of RQ-100 or medicated RQ-100 placed in the donor compartment of a Franz diffusion cell over heat-separated human cadaver skin of 200–400 µm thickness or a 0.45 µm polysulfone membrane. The receptor medium is pH 7.4 phosphate-buffered saline containing 0.5% sodium dodecyl sulfate, maintained at 32°C and stirred at 600 rpm. Sampling is performed at 1, 2, 4, 8, 12, and 24 hours. Data are expressed as cumulative amount permeated per unit area against the square root of time; steady-state flux is reported in µg/cm²/h, and lag time is derived from the linear regression intercept. RQ-100 hydrates the membrane unlike anhydrous petrolatum controls, which changes permeation resistance and can lower lag time for lipophilic actives. To stabilize baseline hydration, the membrane is pre-hydrated at 30°C for 60 min in receptor medium before assembly. Published RQ-100-specific flux data remains limited, so comparative similarity to a reference lot, rather than absolute flux thresholds, forms the acceptance basis. A technical error observed in multi-study comparisons is inconsistent occlusion of the donor compartment; if the donor cell is not sealed, evaporative water loss from RQ-100 raises viscosity during the run and produces a descending flux profile after 8 hours that is not caused by thermodynamic activity.
Pediatric and geriatric skin presents higher transepidermal water loss and reduced dermal thickness, shifting vehicle selection toward water-washable bases such as RQ-100. In compounded neonatal diaper dermatitis preparations, RQ-100 is combined with zinc oxide 10–20 wt% and light mineral oil 5–10 wt%. In geriatric xerosis creams, urea 5–10 wt% or lactic acid 2–5 wt% is incorporated after adjusting the water phase to pH 5.5–6.5 with a citric acid/potassium citrate buffer. Mixing uses a side-scraping agitator at 25–50 rpm; high-shear mixing above 3,000 rpm has been associated with heat build-up above 45°C, which degrades lactic acid and shifts the acid content below label claim. The terminal product is often filled into 15–30 mL tubes or single-dose sachets to reduce preservative load and prevent contamination of multidose containers. Irritation assessment follows ISO 10993-10 or human repeat insult patch testing per ISO 10993-23. Published RQ-100-specific irritation data is limited, but the water phase reduces occlusive epidermal maceration compared with anhydrous petrolatum, and the lamellar structure supports removal with warm water without surfactant scrubbing. Preservative content is a critical control point because pediatric skin has a higher surface-area-to-body-mass ratio than adult skin, and excessive paraben exposure from frequent application is an avoidable burden when single-dose packaging is selected.
| Application segment | RQ-100 loading (wt%) | Active/adjuvant examples | Mixing equipment | Critical process parameter | Terminal packaging |
|---|---|---|---|---|---|
| Extemporaneous corticosteroid cream | 85–97 | hydrocortisone 0.5–2.5, mineral oil 1–3 | mortar/pestle; three-roll mill | roll gap 50–100 µm; roller temperature <25°C | ointment jar 10–60 g |
| Clinical trial placebo | 90–100 | none or calcipotriene 0.1 | vacuum planetary mixer 25–40 rpm, -0.85 bar | air entrainment <0.5 vol% | aluminum tube 15–30 g |
| OTC emollient cream | 85–95 | glycerin 5–10, urea 5–10 | low-shear planetary mixer 50–80 rpm | cooling rate 1°C/min | jar 50–200 mL or airless pump |
| Veterinary topical preparation | 97–99.9 | tacrolimus 0.1, dexamethasone 0.1 | electronic mortar; 5 kg planetary mixer 30 rpm | add white petrolatum 5–10 for hair retention | oral syringe 1 mL graduation |
| Standard/regulation | Designation | Application trigger | Key pass criterion |
|---|---|---|---|
| USP <795> | Non-sterile compounding | extemporaneous prescription compounding | BUD 30 days default; longer only with USP <51> data |
| USP <51> | Antimicrobial effectiveness test | water-containing topical formulations | acceptable log reduction at 7/14/28 days |
| USP <1724> | Semisolid drug product performance | IVRT/quality control | comparative release profile to reference lot |
| 21 CFR 347.10 | OTC skin protectant monograph | OTC labeling | white petrolatum 30–100 wt% |
| ICH Q1A R2 | Stability testing | new topical formulation | 40°C/75% RH for 3–6 months |
| ISO 11930 | Preservative efficacy for cosmetics | leave-on emollient | category 2 log reduction criteria |
| FDA CPG 608.400 | Animal compounding | veterinary topical preparations | documented individual patient need |
Competitive Hydrophilic Ointment RQ-100 prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8618005193850 or mail to sales8@bouling-chem.com.
We will respond to you as soon as possible.
Tel: +8618005193850
Email: sales8@bouling-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Hydrophilic Ointment RQ-100 is a compendial oil-in-water emulsion vehicle manufactured to the United States Pharmacopeia monograph for Hydrophilic Ointment. Its nominal formula is 0.025% methylparaben, 0.015% propylparaben, 1% sodium lauryl sulfate, 12% propylene glycol, 25% stearyl alcohol, 25% white petrolatum, and purified water quantum satis to 100%. The residual water content after accounting for nonaqueous components is 36.96%. In the unmedicated state, RQ-100 is a white to off-white semisolid with an aqueous continuous phase and no active pharmaceutical ingredient. The anionic emulsifier sodium lauryl sulfate and the stearyl alcohol–petrolatum lamellar gel network provide the primary compendial function of a washable, water-miscible base for extemporaneous dermatological compounding under USP <795>. When an active pharmaceutical ingredient is incorporated, the resulting preparation is a compounded nonsterile semisolid subject to beyond-use dating under USP <795>; the unmedicated vehicle is not injectable, ophthalmic, or ingestible.
RQ-100 differs from anhydrous oleaginous bases in a measurable way: the water phase permits aqueous active solutions to be incorporated by dissolution rather than as dispersed solids. The petrolatum fraction is 25%, not a continuous co-solvent; lipophilic actives that require an anhydrous environment should not be assumed to dissolve completely. Published solubility data for the specific RQ-100 configuration with noncompounded actives is limited, so a per-API solubility verification is performed before batch compounding. The product’s model designation RQ-100 identifies the compendial vehicle described above; it is not a final marketed drug product and has no approved NDC label.
Compendial semisolid vehicles are generally classified as oleaginous bases, absorption bases, water-removable o/w emulsion bases, and water-soluble bases. RQ-100 is a water-removable o/w emulsion base because the continuous phase is aqueous and the dispersed phase is composed of 25% white petrolatum plus 25% stearyl alcohol. This classification imposes a specific functional boundary: the base is water-washable and can accept many water-soluble ingredients, but it is not an anhydrous occlusive barrier and it is not a water-absorbing w/o absorption base. The compendial classes are compared in the following table.
| Vehicle class | Compendial example | Continuous phase | Primary performance limit | Reference standard |
|---|---|---|---|---|
| Water-removable o/w emulsion | Hydrophilic Ointment RQ-100 | Aqueous | Anionic surfactant sensitivity; not anhydrous | USP <795>, USP <1151> |
| Oleaginous base | White Petrolatum USP | Non-aqueous | Greasy; difficult to wash; low aqueous capacity | USP <1151> |
| Absorption base | Hydrophilic Petrolatum USP | Oleaginous w/o with water absorption capacity | Potential lanolin-related sensitization in some formulas | USP <1151> |
| Water-soluble base | Polyethylene Glycol Ointment USP | Non-aqueous water-soluble | High glycol content may affect sensitive skin; phenolic incompatibilities possible | USP <1151> |
Production-scale manufacturing of RQ-100 begins with the oil phase: 25% white petrolatum and 25% stearyl alcohol are melted in a jacketed stainless-steel vessel equipped with a counter-rotating sweep agitator. The aqueous phase containing 1% sodium lauryl sulfate, 12% propylene glycol, and the paraben esters is heated separately; the parabens are first predissolved in propylene glycol because their direct solubility in cold water is low. The phases are combined at a temperature that maintains stearyl alcohol in a molten state, typically 60–65°C, and dispersed with a high-shear rotor-stator homogenizer. Cooling is performed under sweep agitation to allow formation of the lamellar gel network. A common batch failure mode occurs when cooling begins before complete homogenization or when the product is cooled too rapidly, resulting in a grainy, low-viscosity, or non-uniform cream. Vacuum deaeration after homogenization removes occluded air and prevents fill-weight variation in final containers. Equipment should be cleaned to avoid carryover of trace cationic residues, which can interact with the anionic emulsifier.
Incoming quality control for unmedicated RQ-100 includes visual inspection for phase separation and grit, pH measurement using USP <791>, and microbial examination according to USP <61> and USP <62> when the vehicle is intended for incorporation into nonsterile compounds. Absence of large undispersed stearyl alcohol crystals is assessed by spreading a thin film on a glass slide under a coverslip and observing at 100× or 400× magnification. If visible crystals or phase separation are present, the batch is rejected before active addition. The paraben esters are present at low concentrations, so a validated high-performance liquid chromatography method can be used to confirm methylparaben and propylparaben assay; the method should be shown to separate both esters from any compounded active.
Sodium lauryl sulfate in RQ-100 is an anionic surfactant. Cationic drug salts such as chlorhexidine gluconate or benzalkonium chloride may form electrostatic complexes with the surfactant, producing visible precipitates or a broken emulsion. Multivalent metal ions can also reduce the stability of the anionic emulsifier system. These interactions are concentration-dependent and are not fully predicted by simple pH adjustment. A stage-based compatibility screen should include visual inspection at 24 h in glass containers, centrifugation, and temperature cycling between refrigerated and ambient conditions when no published data for the specific active form exists. Incompatibilities are not limited to precipitation; anionic-cationic complexation can also lower the available preservative concentration or alter the emulsion droplet size distribution. If the intended API has a cationic charge, a nonionic emulsifier-based vehicle may be preferred unless a specific compatibility study demonstrates stability.
RQ-100 contains 0.025% methylparaben and 0.015% propylparaben. The total paraben concentration is 0.040% w/w in the unmedicated base. Propylene glycol at 12% contributes humectancy and antimicrobial cooperation, but the system is paraben-dependent and is not a substitute for a robust preservation screen. Paraben esters are most active in the undissociated state; reported pKa values for methylparaben and propylparaben fall near 8.0–8.5. At high-pH compounding conditions, the fraction of ionized paraben increases and preservative efficacy can decline even if the total paraben assay remains unchanged. RQ-100 is not formulated for ophthalmic or injectable use, and the manufacturing process does not produce a sterile product. Water content at 36.96% creates a water activity that can support microbial growth if preservative efficacy is compromised by a compounded active. Preservative efficacy should be reassessed according to USP <51> after active incorporation, because some APIs bind parabens, alter phase partitioning, or shift pH.
The unbuffered character of RQ-100 makes it susceptible to pH drift when acidic or basic salts are dissolved in the aqueous phase. A pH measurement with a calibrated glass electrode according to USP <791> is performed for each compounded batch containing an ionizable API. If the pH moves outside the stability window of the API or the paraben system, a noninteracting buffer may be used, but the chosen buffer must not introduce counterions that precipitate with sodium lauryl sulfate. The same limitation applies to pH-adjusting agents; strong acids or bases can hydrolyze the stearyl alcohol–petrolatum gel network if added directly without adequate dilution.
In compounding practice, RQ-100 is used as an o/w vehicle for water-miscible actives and for the preparation of dermatological semisolids that require a water-washable base. Water-soluble active salts are first dissolved in a minimum amount of purified water or a compatible cosolvent and then incorporated by geometric dilution. Low-dose lipophilic actives may be incorporated as micronized suspensions, but particle size distribution must be controlled to avoid a gritty end product. Small batches are prepared with a mortar and pestle or an electronic ointment mill; larger batches are processed with a planetary mixer equipped with wall scrapers or a three-roll mill. The unmedicated base should be at controlled room temperature as defined in USP <659> before active incorporation to avoid phase inversion or loss of volatile components. Final packaged preparations should be placed in tight, light-resistant containers. Because published data for RQ-100-specific active combinations is limited, scale-up beyond 1 kg should include a pilot batch with rheological and globule-size verification using USP <911> and USP <429> where applicable.
The continuous water phase of RQ-100 can accept limited amounts of aqueous and low-carbon alcohol solutions, but excessive additions of ethanol or isopropanol disrupt the lamellar network and produce a runny, phase-separated product. Because the stearyl alcohol plus white petrolatum phase represents only 50% of the formula, nonpolar solvent capacity is limited. Published data for this specific configuration is limited. A solubility and compatibility screen in a closed vessel at 20–25°C is recommended before committing to a solvent-containing formula; the point at which the emulsion thins to a watery consistency or separates marks the practical solvent boundary. RQ-100 is not appropriate for preparing anhydrous pastes, w/o extracts, or high-load organic solvent preparations. If the API requires a predominantly organic solvent system, an anhydrous or w/o absorption base is a more appropriate platform.
At pilot scale, the most informative process variable is the cooling rate after homogenization. If cooling is too fast, stearyl alcohol crystallizes as large platelets rather than forming the fine gel network, and the product may develop visible graininess within 24 h. If cooling is too slow, the emulsion may be subjected to excessive sweep shear, which can reduce yield stress and produce a softer product. Acceptable cooling depends on vessel size, sweep speed, and wall temperature; batch records should log jacket temperature and product temperature at fixed intervals. A pilot run should confirm the gel-network setting point for the specific vessel geometry before scale-up to full production.
Because RQ-100 contains water, physical stability of compounded preparations depends on the API’s effect on the lamellar gel network. Hygroscopic active salts can draw water from the continuous phase and raise local ionic strength, compressing the electric double layer around anionic surfactant micelles. This may lead to creaming or droplet coalescence. A short-term accelerated screening at 40°C and 75% relative humidity for 14 days is commonly used for semisolid formulation screening, but published data for RQ-100 with specific APIs is limited; a negative result in the screening does not replace a full beyond-use dating assignment under USP <795>. Rheological measurements before and after storage using a rotational viscometer per USP <911> can detect gel-network breakdown before visual phase separation occurs. If the active is nonionic and highly surface-active, it can displace or compete with sodium lauryl sulfate at the droplet interface, requiring a lower active load or a different vehicle.
Differences from other products are most pronounced with respect to occlusivity, irritation potential, and ionic character. White Petrolatum USP is essentially anhydrous and forms a continuous oleaginous barrier; RQ-100 contains only 25% petrolatum and 36.96% water, producing lower occlusive performance but better washability. Hydrophilic Petrolatum USP is an absorption base that accepts aqueous solutions by forming a w/o system, whereas RQ-100 is already an o/w system and does not require the same water uptake. Polyethylene Glycol Ointment USP is water-soluble and greaseless, but its high glycol content can draw water from tissue and may be incompatible with certain phenolic actives. RQ-100 contains no lanolin and no polyethylene glycol, which is relevant for patients with known lanolin or PEG sensitivity, but it does contain 1% sodium lauryl sulfate and 12% propylene glycol; both can produce stinging or irritation on compromised skin or mucosal surfaces. Nonionic emulsifier-based creams may be preferred for cationic actives or high-sensitivity dermatoses because they avoid the anionic incompatibility of SLS.
For dermal application on intact skin, RQ-100 may be applied as a thin film. Application to broken skin, abraded skin, or mucosal surfaces requires a risk-based decision because sodium lauryl sulfate at 1% and propylene glycol at 12% can provoke local irritation. The unmedicated vehicle is not sterilized; use on immunocompromised patients or denuded skin should follow institutional infection-control protocols and USP <795>. Occlusive dressings may increase systemic absorption of any compounded active; beyond-use dating is determined by the compounded preparation’s water content, preservative efficacy, and storage temperature. Aqueous phase evaporation from a patient-ready container can change the effective active concentration over time; closures should remain tight, and storage should follow the assigned beyond-use date rather than extending use of the open container.
Dedicated to excellence in chemistry — serving industries worldwide with integrity and innovation.
