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Isotretinoin
Isotretinoin Specification
- EINECS No
- 225-315-6
- Solubility
- Insoluble in water; soluble in organic solvents such as ethanol, DMF, and DMSO
- Heavy Metal (%)
- 0.001%
- Color
- Yellow to orange
- Molecular Weight
- 300.44 g/mol
- Ph Level
- Not applicable (neutral)
- Storage
- Store at 2C to 8C, protect from light
- Boiling point
- Does not boil, decomposes
- Molecular Formula
- C20H28O2
- Shelf Life
- 24 months
- Loss on Drying
- 0.5%
- Particle Size
- Micronized form available, typically <10 microns
- Taste
- Bitter
- Smell
- Characteristic odour
- HS Code
- 29362100
- Structural Formula
- C20H28O2 (refer to image for structure)
- Poisonous
- Yes, toxic in high doses; teratogenic
- Melting Point
- 174-175C
- Medicine Name
- Isotretinoin
- Chemical Name
- 13-cis-Retinoic Acid
- CAS No
- 4759-48-2
- Type
- Other
- Grade
- Other
- Usage
- Used for the treatment of severe acne; also studied for other skin disorders
- Purity(%)
- 99%
- Appearance
- Yellow to orange crystalline powder
- Physical Form
- Powder
- Impurity Level
- Individual impurity 0.2%
- Residual Solvents
- Meets USP/Ph. Eur. standards
- Assay (by HPLC)
- >= 99%
- Packaging
- Double PE bags with aluminum foil outer packaging, 1kg/bag, 5kg/drum
- Optical Rotation
- -15 to -20 (c=1, CHCl3)
- Manufacturing Standard
- USP/EP/CP
- Identification
- Complies with standard IR and UV/Vis spectra
Isotretinoin Trade Information
- Minimum Order Quantity
- 1 Kilograms
- Supply Ability
- 2000 Kilograms Per Day
- Delivery Time
- 1 Days
About Isotretinoin
We are offering premium quality Isotretinoin in various sterile packaging options. This type of drug is ideal to be utilized for the treatment of severe cystic acne which is also known as nodular acne. Available in capsule form, it contains Isotretinoin as the active ingredient that belongs to the group of drugs known as retinoid. Isotretinoin is very helpful in providing relief from acne by decreasing the facial oil (sebum) production that can lead to severe acne when produced in high amounts.
Pharmaceutical-Grade Quality and Rigorous Standards
Our Isotretinoin offers unparalleled purity (99%) and complies with major pharmacopeial standards (USP/EP/CP). Stringent HPLC testing ensures individual impurities are maintained at 0.2%. Residual solvents meet USP/Ph. Eur. benchmarks, guaranteeing both safety and efficacy for end users. The products high degree of quality assurance makes it a trusted choice for pharmaceutical applications.
Specialized Packaging and Product Stability
To preserve its integrity, Isotretinoin is securely packaged in double PE bags with an aluminum foil outer layer, available in 1kg and 5kg options. This packaging design, together with optimal storage conditions (2C8C, protection from light), helps maintain the products crystalline structure, extends its shelf life up to 24 months, and prevents contamination or degradation.
Targeted Usage and Clinical Benefits
Isotretinoin is essential in dermatology, notably as an effective treatment for severe acne and certain other skin disorders. Its high potency, consistent micronized particle size, and stringent impurity controls offer significant therapeutic benefits, leading to improved bioavailability, rapid action, and better patient outcomes in clinical and research settings.
FAQs of Isotretinoin:
Q: How should Isotretinoin be stored to maximize its shelf life and maintain potency?
A: Isotretinoin should be stored at temperatures between 2C and 8C, protected from light, to preserve its chemical integrity. Proper storage under these conditions ensures the crystalline powder remains stable and effective throughout its 24-month shelf life.Q: What is the process by which the purity and quality of Isotretinoin are ensured?
A: Purity is confirmed using HPLC analysis, with assays guaranteeing a minimum of 99% purity and individual impurities kept at or below 0.2%. The product also undergoes stringent IR and UV/Vis spectrum identification and meets USP/Ph. Eur. residual solvent standards, ensuring pharmaceutical-grade quality.Q: Why is Isotretinoin considered toxic and what precautionary measures should be taken during handling?
A: Isotretinoin is toxic in high doses and has teratogenic properties (can cause birth defects). Appropriate handling measures include the use of protective clothing, gloves, and masks, and avoiding ingestion or direct skin contact to reduce associated risks.Q: What are the main pharmaceutical applications and benefits of Isotretinoin?
A: Isotretinoin is mainly used to treat severe forms of acne, particularly those unresponsive to conventional therapies. The benefit lies in its high efficacy for severe dermatological cases, leading to clear skin for many patients where other treatments have failed.Q: When should micronized Isotretinoin powder be selected over standard forms?
A: Micronized Isotretinoin, with particle sizes typically less than 10 microns, should be selected when enhanced absorption and bioavailability are needed, such as in specialized formulations or where rapid therapeutic response is desired.Q: Where is Isotretinoin manufactured and how is it distributed?
A: Our Isotretinoin is manufactured in India, following USP/EP/CP standards, and is available for export, distribution, and supply globally. Packaging options include 1kg and 5kg quantities to accommodate various scales of pharmaceutical production and research needs.Q: What solvents can be used to dissolve Isotretinoin for laboratory or formulation purposes?
A: Isotretinoin is insoluble in water, but readily dissolves in organic solvents such as ethanol, dimethylformamide (DMF), and dimethyl sulfoxide (DMSO), making these suitable choices for laboratory preparations and product formulations.Price 100 INR/ Kilograms
- Minimum Order Quantity
- 1 Kilograms
- Supply Ability
- 2000 Kilograms Per Day
- Delivery Time
- 1 Days
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