Dienogest Active Pharmaceutical Ingredients

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Dienogest Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Dienogest Active Pharmaceutical Ingredients Specification

HS Code
29372900

Heavy Metal (%)
0.001%

Molecular Weight
311.42 g/mol

Ph Level
Neutral (not applicable in solid form)

Taste
Tasteless

Melting Point
210C - 215C

Loss on Drying
0.5%

Solubility
Practically insoluble in water, freely soluble in dichloromethane, soluble in acetone and methanol

Boiling point
Not applicable (decomposes before boiling)

Color
White

Structural Formula
C20H25NO2 (refer to structural diagram for exact chemical structure)

Molecular Formula
C20H25NO2

EINECS No
265-724-3

Storage
Store in tightly closed container, dry and cool place, protected from light

Particle Size
Micronized, 10 m

Shelf Life
5 years if properly stored

Smell
Odorless

Poisonous
No (when handled as recommended, for pharmaceutical use only)

Medicine Name
Dienogest

Chemical Name
(17)-17-Hydroxy-3-oxo-19-nor-17-pregna-4,9-diene-21,17-carbolactone

CAS No
65928-58-7

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used for the treatment of endometriosis, often in oral contraceptives

Purity(%)
>= 99%

Appearance
White or almost white crystalline powder

Physical Form
Solid

Specific Optical Rotation
+66 to +76 (in methanol)

Toxicity
No data of acute toxicity for API

Related Substances
Total impurities 1.0%

Assay Method
HPLC, NLT 99.0%

Identification
IR, HPLC compliant

Residual Solvents
Within ICH limits

Regulatory Status
DMF available, GMP compliant

Packing
HDPE Drum with double polyethylene liners / Aluminum bags

Microbial Limits
USP/EP compliant

Dienogest Active Pharmaceutical Ingredients Trade Information

Minimum Order Quantity
25 Kilograms

Payment Terms
Cash Against Delivery (CAD), Cash on Delivery (COD), Cash in Advance (CID)

Supply Ability
500 Kilograms Per Month

Delivery Time
5-7 Days

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

Main Domestic Market
All India

Dienogest Active Pharmaceutical Ingredients About

Access the eminent quality Dienogest Active Pharmaceutical Ingredient (API), a trending solution for the medical sector's evolving needs. Our superb pharmaceutical-grade Dienogest, with a towering purity level of 99%, showcases consistency in every batch. This API is recognized for its specific optical rotation (+66 to +76 in methanol), HPLC and IR compliance, and minimal residual solvents within ICH limits. Packed securely in HDPE drums with double polyethylene liners or aluminum bags, and supported by DMF and GMP certifications, it is a leading choice for endometriosis treatments and oral contraceptive formulations. Sourced from India, Dienogest meets stringent USP/EP microbial standards, ensuring top-tier safety and efficacy in pharmaceutical applications.

Used By, Advantages, Usage & Applications of Dienogest API

Dienogest Active Pharmaceutical Ingredient is used by pharmaceutical manufacturers and healthcare innovators. Its advantage lies in its high purity (99%) and eminent compliance with regulatory standards, making it a favored choice in the formulation of oral contraceptives and endometriosis treatments. Its superb stability and solubility profile support wide-ranging applications in hormone therapy medicines. As a tasteless, odorless, white crystalline powder, Dienogest ensures seamless integration in various dosage forms for reliable patient outcomes.

Dienogest API: Domestic Market, Supply Ability & Export Reach

Dienogest API services a towering domestic pharmaceutical outlay with a strong presence across India's medical landscape. With robust supply ability, shipments are delivered efficiently, reaching out to key markets. The main export destinations span across Europe, Southeast Asia, and other global regions. Each outlay ensures compliance with international quality standards, guaranteeing prompt and secure shipment to clients worldwide. Delivered with regulatory documentation, Dienogest offers both local and international partners a secure, reliable source for their pharmaceutical needs.

FAQ's of Dienogest Active Pharmaceutical Ingredients:

Q: How should Dienogest Active Pharmaceutical Ingredient be stored to maintain its efficacy?

A: Dienogest API should be stored in a tightly closed container, in a dry and cool place, and protected from light. Proper storage conditions help preserve its stability and extend its shelf life up to five years.

Q: What are the primary uses of Dienogest API in pharmaceutical preparations?

A: Dienogest API is primarily used for the treatment of endometriosis and is a key ingredient in oral contraceptives. It serves as a hormonal agent to manage and alleviate symptoms in patients.

Q: When should I consider using Dienogest API in manufacturing processes?

A: Consider using Dienogest API when manufacturing pharmaceutical formulations targeted at endometriosis treatment or oral contraceptive products, ensuring the need for high purity and regulatory compliance is met.

Q: Where is Dienogest API mainly exported, and what markets does it serve?

A: Dienogest API is mainly exported from India to Europe, Southeast Asia, and other international markets, serving a diverse range of pharmaceutical manufacturers and suppliers engaged in hormone therapy medicine production.

Q: What quality standards and certifications does Dienogest API comply with?

A: Dienogest API complies with GMP practices, is DMF available, and meets USP/EP microbial limits. It is also compliant with ICH limits regarding residual solvents and is tested via HPLC and IR identification methods.

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