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Bulk Drug Substance

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Bulk Drug Substance Specification

Assay
> 99%

Melting Point
Varies depending on product

Place of Origin
India

Ph Level
Not less than 6.0

Molecular Formula
Varies depending on substance

Moisture (%)
0.5%

HS Code
29339900

Loss on Drying
0.5%

Molecular Weight
Varies depending on compound

Storage
Cool & Dry Place

Heavy Metal (%)
<0.001%

Particle Size
10-80 microns

Residue on Ignition
0.1%

Other Names
API, Active Pharmaceutical Ingredient

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Pharma Intermediates, Medicine Formulation

Purity
99% Min

Appearance
Fine Powder

Application
Pharmaceutical, Bulk Drug Manufacturing

Raw Material
Pharma Bulk Drug

Smell
Odorless

Color
White

Form
Powder

Shelf Life
24 months

Solubility
Soluble in water and organic solvents

Packaging Type
HDPE Drum, Double PE Bags

Identification
Complies with reference standard

Microbial Limits
Complies with pharmacopeial standards

Country of Supply
India

Stability
Stable under recommended storage conditions

End Use
Formulation of finished dosage forms

About Bulk Drug Substance

Bulk Drugs are an active pharmaceutical ingredient that are used as the main ingredient in a pharmaceutical product. They are substances that are majorly responsible for the product being a medicine. Bulk Drugs include sulpha drugs, antibiotics, vitamins, and analgesics.

Unmatched Purity and Safety

With a minimum purity of 99% and verified by assays, the bulk drug substance offers consistent quality and compliance with pharmacopeial standards. Each batch undergoes rigorous testing for microbial limits, residue on ignition, heavy metals, moisture, and other critical parameters, ensuring that it meets the highest benchmarks of safety and efficacy.

Versatile Pharmaceutical Application

Perfect for medicine formulation, pharma intermediates, and the bulk drug manufacturing process, this API adapts seamlessly into various finished dosage forms. Its fine, odorless white powder form, customizable molecular details, and excellent solubility allow ease of integration into multiple pharmaceutical preparations and processes.

Secure Packaging and Reliable Supply

Packaged in robust HDPE drums with double-layered PE bags, the substance maintains integrity and prevents contamination during shipping and storage. With a shelf life of 24 months and supplied directly from India, it offers pharmaceutical companies and distributors a secure and consistent raw material source.

FAQs of Bulk Drug Substance:

Q: How should the bulk drug substance be stored to maintain its stability and shelf life?

A: The substance should be stored in a cool, dry place in its original HDPE drum and double PE bag packaging. Proper storage under recommended conditions ensures the product remains stable and retains its 24-month shelf life.

Q: What is the primary benefit of using this API in pharmaceutical manufacturing?

A: Its high purity (over 99%) and excellent solubility in water and organic solvents make it ideal for efficient formulation, promoting consistent dosage and efficacy in finished pharmaceutical products.

Q: What steps are involved in the quality assurance process for this bulk drug substance?

A: Each batch is tested according to pharmacopeial standards for identification, microbial limits, residue on ignition, heavy metals, assay, moisture, and more. This rigorous process guarantees compliance, safety, and performance.

Q: Where does the API originate and who can purchase it?

A: This API is manufactured and supplied from India. It is available to distributors, importers, suppliers, traders, wholesalers, and pharmaceutical manufacturers seeking a reliable source for bulk pharmaceutical raw materials.

Q: How is the bulk drug substance typically used in medicine formulation?

A: It serves as the base active ingredient in pharmaceutical products. As a fine, odorless, white powder, it is easily blended with excipients and other ingredients to create various dosage forms like tablets, capsules, and injectables.

Q: What precautions should be taken during handling and processing?

A: Personnel should handle the API in accordance with Good Manufacturing Practices (GMP), using personal protective equipment to prevent contamination and inhalation, and ensuring the material is not exposed to excessive moisture or heat.

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