Isotretinoin Active Pharmaceutical Ingredients

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Isotretinoin Active Pharmaceutical Ingredients

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Isotretinoin Active Pharmaceutical Ingredients Specification

Loss on Drying
NMT 0.5%

Ph Level
Not applicable/Not available

Heavy Metal (%)
NMT 0.001%

Shelf Life
24 months

Particle Size
Complies as per pharmacopeia

Molecular Weight
300.44 g/mol

Melting Point
172-175C

Solubility
Practically insoluble in water; soluble in organic solvents like dimethyl sulfoxide, ethanol

Structural Formula
C20H28O2

Boiling point
Not available (decomposes)

Storage
Store in a cool, dry place; protect from light

Smell
Odorless

Taste
Bland

Poisonous
Non-poisonous at therapeutic doses; toxic in overdose

Color
Yellow to orange

HS Code
29362100

EINECS No
225-334-9

Molecular Formula
C20H28O2

Medicine Name
Isotretinoin

Chemical Name
13-cis-Retinoic Acid

CAS No
4759-48-2

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Treatment of severe acne; used in dermatology

Purity(%)
>= 99.0

Appearance
Yellow to orange crystalline powder

Physical Form
Solid

Identification
By IR and UV absorption

Residual Solvent
Complies with ICH Q3C

Pharmacopeia Standard
USP/EP/BP

Related Substances
NMT 0.5%

Minimum Order Quantity
1 kg

Microbial Limit
Should not exceed limits as per pharmacopeia

Packaging
Sealed double polythene bags in HDPE drums

Assay (by HPLC)
>= 99.0%

Isotretinoin Active Pharmaceutical Ingredients Trade Information

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Isotretinoin Active Pharmaceutical Ingredients About

Jump on a heroic solution for severe acne with our Isotretinoin Active Pharmaceutical Ingredient (API)-your enlightened choice for noteworthy dermatological applications. Crafted with a purity of >= 99.0% and validated by strict USP/EP/BP standards, this product showcases reliability. Identification is meticulously confirmed by IR and UV absorption, and all properties comply with ICH Q3C guidelines. Packaged securely in sealed double polythene bags within HDPE drums, every 1kg minimum order is designed for superior transport. Try Now to introduce a transformative, pharmaceutical-grade API to your medication roster.

Widespread Applications for Dermatology and Beyond

Isotretinoin API is renowned for its efficacy in advanced dermatology clinics, cosmetic centers, and pharmaceutical manufacturing units. Used primarily for the treatment of severe, recalcitrant acne, it offers enlightened results where standard therapies have failed. The crystalline powder is used as a vital ingredient in sophisticated formulations, making it a noteworthy addition for prescription medicine compounding, clinical studies, and research purposes. Its pharmaceutical grade and high purity ensure safety for every type of usage.

Certifications, Order Process, and Shipping Policies

Our Isotretinoin API holds certifications as per USP/EP/BP pharmacopeia standards, ensuring clients receive pharmaceutical-grade quality. Proposal amount and invoicing can be tailored to batch requirements, with flexible payment terms for streamlined transactions. Dispatching and logistics are handled efficiently, deploying double polythene bags in robust HDPE drums for safe transport. Sample policies are transparent-upon request, eligible parties may receive samples under specific agreements, facilitating confident decision-making ahead of bulk procurement.

FAQ's of Isotretinoin Active Pharmaceutical Ingredients:

Q: How is the quality of Isotretinoin API confirmed before shipping?

A: Quality is verified by identification using IR and UV absorption, assay by HPLC (>=99.0%), and strict compliance with pharmacopeia and ICH Q3C residual solvent standards.

Q: What are the main benefits of using Isotretinoin API in pharmaceuticals?

A: Its high purity and compliance with global pharmacopeia standards make it noteworthy for effective severe acne treatments, providing reliable results where other therapies may be insufficient.

Q: When is Isotretinoin typically used in dermatology?

A: It is prescribed for severe or recalcitrant acne cases that do not respond to conventional therapies, elevating skin care outcomes significantly.

Q: Where should the Isotretinoin API be stored for optimal shelf life?

A: Store the product in a cool, dry place, protecting it from light to maintain its effectiveness for up to 24 months.

Q: What is the process for ordering and receiving Isotretinoin API from your company?

A: Orders begin with a proposal amount and clear invoicing. Upon agreement, dispatching is managed via secure packaging in HDPE drums, and logistics ensure timely delivery to your location.

Q: How can users obtain a sample of Isotretinoin API before placing a bulk order?

A: Eligible clients may request samples under specific, transparent sample policies, allowing product evaluation before committing to larger quantities.

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