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Adapalene Api
Adapalene Api Specification
- Loss on Drying
- 0.5%
- Molecular Weight
- 412.52 g/mol
- Structural Formula
- C28H28O3
- Color
- White
- Molecular Formula
- C28H28O3
- Smell
- Odorless
- HS Code
- 29332990
- Heavy Metal (%)
- 0.001%
- Particle Size
- Micronized, typically <10 micron
- Poisonous
- Non-poisonous as per pharmaceutical grade
- Melting Point
- 314-316C
- Storage
- Store in a cool, dry place away from light
- EINECS No
- --
- Solubility
- Insoluble in water, soluble in polar organic solvents
- Shelf Life
- 2 years
- Medicine Name
- Adapalene API
- Chemical Name
- Adapalene
- CAS No
- 106685-40-9
- Type
- Other
- Grade
- Other
- Usage
- Pharmaceutical raw material, used mainly for the treatment of acne
- Purity(%)
- 99%
- Appearance
- White to off-white powder
- Physical Form
- Solid
- Related Substances
- 0.1%
- Sulphated Ash
- 0.1%
- Stability Data
- Available upon request
- Assay (by HPLC)
- 99%
- Residual Solvents
- In compliance with ICH guidelines
- Microbial Limit
- Complies with pharmacopeia standards
- Polymorphic Form
- Crystalline Form I
- Packing
- HDPE Drum with double polybags, or as required
- Chloride Content
- 0.02%
Adapalene Api Trade Information
- Minimum Order Quantity
- 1 Kilograms
- Supply Ability
- 2000 Kilograms Per Day
- Delivery Time
- 1 Days
About Adapalene Api
Specification
| Product | Status | CAS No. |
|
| Tech pack | 28981-97-7 |
| USDMF & CEP | 129722-12-9 | |
| Atomoxetine HCl | CEP+, USDMF & TDMF | 82248-59-7 |
| Betahistine Dihydrochloride^ | CEP | 5579-84-0 |
| Betahistine Mesylate | Tech pack | 54856-23-4 |
| Cilostazol | Tech pack | 73963-72-1 |
| Clozapine | USDMF* & CEP* | 5786-21-0 |
| Dexmethylphenidate HCl | Tech pack | 19262-68-1 |
| Felbinac^ | EDMF* & JDMF* | 5728-52-9 |
| Flupirtine Maleate | Tech pack | 75507-68-5 |
| Fluvoxamine Maleate^ | CEP, USDMF & TDMF | 61718-82-9 |
Pharmaceutical Excellence for Acne Treatment
Adapalene API is recognized for its efficacy and reliability in acne management. Its stringent quality specifications and pharmaceutical-grade purity ensure it meets the demands of global manufacturers. With superior stability and compliance with international guidelines, it is the preferred choice for formulators developing safe and effective dermatological therapies.
Strict Quality and Safety Compliance
Every batch of Adapalene API undergoes rigorous testing for related substances, residual solvents, microbial limits, heavy metals, and more. The crystalline Form I guarantees consistent performance, while packaging in HDPE drums with double polybags maintains integrity during distribution and storage. Detailed stability data are available upon request to support regulatory submissions.
FAQs of Adapalene Api:
Q: How should Adapalene API be stored for optimal stability?
A: Adapalene API should be stored in a cool, dry place away from direct light, using its original HDPE drum with double polybags or equivalent packaging. Ensuring proper storage helps maintain its stability and extends its shelf life to up to two years.Q: What is the main usage of Adapalene API in pharmaceuticals?
A: Adapalene API is primarily used as a key ingredient in the formulation of topical treatments for acne. Its high purity and controlled particle size make it ideal for dermatological applications.Q: When is Adapalene API typically used during pharmaceutical manufacturing?
A: Adapalene API is incorporated during the active pharmaceutical ingredient (API) phase, prior to formulation into creams, gels, or lotions for the treatment of acne. It is handled under strict quality controls to ensure consistency and safety.Q: Where does Adapalene API originate, and who supplies it?
A: Adapalene API is produced in India and supplied globally by manufacturers, exporters, distributors, importers, traders, and suppliers who adhere to international quality standards.Q: What quality control measures are in place for Adapalene API?
A: Adapalene API is tested for related substances (0.1%), residual solvents (ICH compliance), chloride content (0.02%), sulphated ash (0.1%), heavy metals (0.001%), microbial limits, and assay (99%) using HPLC. It also meets standards for particle size and loss on drying (0.5%).Q: How does the crystalline Form I of Adapalene API benefit its application?
A: The crystalline Form I of Adapalene API ensures consistent physicochemical properties, improving its performance in formulation and stability in finished pharmaceutical products.Q: What are the solubility properties and benefits of Adapalene API?
A: Adapalene API is insoluble in water but soluble in polar organic solvents. This aids its processing and incorporation into various pharmaceutical formulations designed for topical application.Price 100 INR/ Kilograms
- Minimum Order Quantity
- 1 Kilograms
- Supply Ability
- 2000 Kilograms Per Day
- Delivery Time
- 1 Days
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