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Norethisterone Acetate API

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MOQ : 25 Kilograms

Norethisterone Acetate API Specification

Loss on Drying
Not more than 0.5%

Heavy Metal (%)
Not more than 0.001%

Storage
Store in a cool, dry place, protected from light

Structural Formula
C22H28O3

Molecular Weight
340.46 g/mol

Color
White to Off-White

Melting Point
205-208C

Smell
Odorless

Molecular Formula
C22H28O3

Solubility
Slightly soluble in chloroform and methanol, insoluble in water

Poisonous
Non-poisonous under recommended usage

Particle Size
90% passes through 60 mesh

Shelf Life
36 months

HS Code
29372900

EINECS No
200-132-3

Medicine Name
Norethisterone Acetate API

Chemical Name
17-Acetoxy-19-nor-17-pregn-4-en-20-yn-3-one

CAS No
51-98-9

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the formulation of oral contraceptives and hormone therapy

Purity(%)
>99%

Appearance
White to Off-White Crystalline Powder

Physical Form
Solid

Certificate of Analysis
Available with each batch

Residual Solvents
Complies with ICH guidelines

Microbial Limit Test
Complies with pharmacopeial standards

Related Substances
Not more than 0.2%

Manufacturing Standard
GMP certified facility

Identification
Complies with standard reference

Packaging
Packed in double polyethylene bags, placed in fiber drums of 5kg/10kg/25kg

Assay (By HPLC)
Not less than 99.0%

Specific Optical Rotation
+50 to +54 (C=1, in dioxane)

Norethisterone Acetate API Trade Information

Minimum Order Quantity
25 Kilograms

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

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

About Norethisterone Acetate API

Norethisterone Acetate API, a pharmaceutical grade active ingredient, takes the spotlight for its outstanding purity (>99%) and optimum quality. Complying with stringent standards, including ICH guidelines and pharmacopeial requirements, this top-drawer API ensures reliable performance in the formulation of oral contraceptives and hormone therapy products. Each batch comes with a certificate of analysis, guaranteeing traceability and value. Sourced from a GMP certified facility in India, its promotion as a safe, odorless, non-poisonous powder is backed by rigorous quality controls, tailored for pharmaceutical exporters, suppliers, and traders seeking excellence.

Key Applications and Enhanced Features of Norethisterone Acetate API

Norethisterone Acetate API exhibits a surface of application centered in the pharmaceutical industry, particularly for oral contraceptives and hormone replacement therapy. Notably, it features outstanding purity, precise assay by HPLC (99%), and controlled physical characteristics, ensuring efficacy and safety. Its extra features include a consistent particle size (90% through 60 mesh) and exceptional stability, due to a shelf life of 36 months. The slightly soluble profile in chloroform and methanol offers versatility in drug formulation for optimal use cases.

Packing, Drop-off, and Supply Details for Norethisterone Acetate API

Norethisterone Acetate API is packed in double polyethylene bags, placed securely into fiber drums available in 5kg, 10kg, or 25kg sizes to maintain integrity throughout drop-off and delivery. Packing & dispatch are executed with precision, ensuring swift charge to order processing and global supply demands. Supply ability and timelines are rigorously managed, enabling prompt delivery with every charge, while careful storage conditions are provided to preserve quality during transit, making us a trusted partner for pharmaceutical businesses worldwide.

FAQ's of Norethisterone Acetate API:

Q: How is the quality of Norethisterone Acetate API assured?

A: The quality of Norethisterone Acetate API is assured through compliance with standard reference identification, rigorous assay testing (by HPLC not less than 99.0%), and adherence to ICH guidelines on residual solvents. Each batch is produced in a GMP certified facility and accompanied by a certificate of analysis.

Q: What are the main applications of Norethisterone Acetate API?

A: Norethisterone Acetate API is primarily used in the formulation of oral contraceptives and hormone therapy medications, owing to its high purity and pharmaceutical-grade specifications.

Q: When should Norethisterone Acetate API be stored or handled to maintain its properties?

A: This API should be stored in a cool, dry place, protected from light, to maintain its stability and efficacy throughout its 36-month shelf life.

Q: Where is Norethisterone Acetate API exported and supplied from?

A: Norethisterone Acetate API is exported, supplied, and traded globally from India, where it is manufactured in GMP certified facilities.

Q: What is the packing and drop-off process for delivery?

A: The API is meticulously packed in double polyethylene bags and fiber drums of various sizes (5kg/10kg/25kg) to ensure contamination-free delivery. Packing and dispatch are designed for efficient charge and on-time drop-off worldwide.

Q: How does the API benefit pharmaceutical manufacturers?

A: Pharmaceutical manufacturers benefit from its outstanding purity, consistent quality, compliance with international standards, and reliable supply, making it an optimum choice for mainstream drug formulation.

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