Mebendazole Micronized GMP certified manufacturer

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Mebendazole Micronized GMP certified manufacturer

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MOQ : 25 Kilograms

Mebendazole Micronized GMP certified manufacturer Specification

HS Code
29332990

Shelf Life
5 years

Moisture (%)
NMT 0.5%

Structural Formula
C16H13N3O3

Heavy Metal (%)
NMT 0.002%

Storage
Store in a tightly closed, light-resistant container at room temperature (15-25C)

EINECS No
250-635-4

Taste
Tasteless

Grade
IP/USP

Smell
Odorless

Water Solubility
Practically insoluble in water, soluble in formic acid and slightly soluble in ethanol

Loss on Drying
NMT 0.5%

Ph Level
Neutral

Molecular Weight
295.30 g/mol

Molecular Formula
C16H13N3O3

Assay
99.0% to 101.0%

Chemical Name
Mebendazole Micronized

CAS No
31431-39-7

Usage
Pharmaceutical raw material, Anthelmintic agent for human and veterinary use

Purity(%)
99%

Appearance
White powder

Application
Used in the treatment of nematode infestations, such as pinworm, whipworm, roundworm, and hookworm infections

Packaging
25 kg fiber drum

Related Substances
Total impurities NMT 0.5%

Particle Size
Micronized (D90 <10 microns)

Residual Solvent
Complies with ICH guidelines

Impurity Content
NMT 0.1%

Melting Point
288-292C

Compatibility
Compatible with common pharmaceutical excipients

Manufacturing Process
Micronized for high bioavailability

Mebendazole Micronized GMP certified manufacturer Trade Information

Minimum Order Quantity
25 Kilograms

FOB Port
mundra

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
1000 Kilograms Per Week

Delivery Time
7 Days

Sample Available
Yes

Sample Policy
Contact us for information regarding our sample policy

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 Mebendazole Micronized GMP certified manufacturer

Mebendazole Micronized GMP is a high-quality anthelmintic API for parasitic infections. It's effective against various worms like pinworms and hookworms. Often used in human and veterinary medicine for deworming. Micronized for improved bioavailability and efficacy. Manufactured under Good Manufacturing Practice standards for quality assurance.

High Bioavailability and Purity

The micronization of Mebendazole ensures a particle size (D90 <10 microns), which results in improved bioavailability and therapeutic efficiency. Coupled with an assay of 99.0% to 101.0% and total impurities NMT 0.5%, this pharmaceutical grade ingredient guarantees high purity and consistent performance for end formulations.

Stringent Quality and GMP Certification

Our Mebendazole Micronized is produced under GMP-certified conditions, aligning with IP/USP and international safety standards. It complies with ICH guidelines for residual solvents and heavy metal content, and features a loss on drying of NMT 0.5%, making it a reliable choice for global pharmaceutical needs.

FAQ's of Mebendazole Micronized GMP certified manufacturer:

Q: How is Mebendazole Micronized manufactured for increased bioavailability?

A: Mebendazole Micronized is produced using a micronization process that reduces particle size (D90 <10 microns), enhancing absorption and bioavailability in therapeutic applications.

Q: What are the recommended storage conditions for Mebendazole Micronized?

A: This product should be stored at room temperature (15-25C) in a tightly closed, light-resistant container to maintain its stability and 5-year shelf life.

Q: When should Mebendazole Micronized be used as a pharmaceutical raw material?

A: Mebendazole Micronized is recommended for use in formulations intended to treat nematode infestations, such as pinworm, whipworm, roundworm, and hookworm infections in both humans and animals.

Q: Where is your manufacturing facility located and is it GMP certified?

A: Our facility is located in India and is fully GMP certified, ensuring our Mebendazole Micronized meets stringent pharmaceutical quality and safety standards.

Q: What is the compatibility of Mebendazole Micronized with pharmaceutical excipients?

A: Mebendazole Micronized is compatible with common pharmaceutical excipients, making it suitable for various dosage forms and formulations.

Q: How does your Mebendazole Micronized comply with international quality requirements?

A: The product meets IP/USP grade specifications, complies with ICH guidelines for residual solvents, and limits heavy metals to NMT 0.002%, guaranteeing global regulatory acceptance.

Q: What are the benefits of choosing your Mebendazole Micronized as a raw material?

A: Choosing our GMP-certified Mebendazole Micronized provides high purity, consistent particle size, regulatory compliance, and superior bioavailability for high-quality pharmaceutical formulations.

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