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Clindamycin Powder Api

Price 9500.0 INR/ Piece

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MOQ : 100 Pieces

Clindamycin Powder Api Specification

Molecular Weight
424.98 g/mol

Color
White to off-white

Heavy Metal (%)
Not more than 0.001%

Storage
Store in a tightly closed container, in a cool, dry, well-ventilated area, protected from light

Particle Size
90% passing through 60 mesh

Boiling point
Not applicable (decomposes)

Solubility
Freely soluble in water, slightly soluble in methanol, practically insoluble in chloroform

Taste
Bitter

Melting Point
139-144C

HS Code
29419090

Loss on Drying
Not more than 1.0%

Shelf Life
5 years under recommended storage conditions

Ph Level
4.0-6.0 (1% aqueous solution)

EINECS No
242-690-2

Poisonous
Non-poisonous under prescribed pharmaceutical use

Structural Formula
Available upon request (refer to reference standards)

Smell
Odorless or characteristic

Molecular Formula
C18H33ClN2O5S

Medicine Name
Clindamycin Powder API

Chemical Name
Clindamycin

CAS No
18323-44-9

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used for synthesis of clindamycin formulations, treatment of bacterial infections

Purity(%)
>=98%

Appearance
White to off-white powder

Physical Form
Solid

Pharmacopeial Compliance
USP, EP, BP

Optical Rotation
+135 to +150 (c=1, in methanol)

Microbial Limits
Complies with pharmacopeial standards

Certificate of Analysis
Provided with shipment

Residual Solvents
As per ICH guidelines

Registration/DMF
US DMF, CEP available (on request)

Sterility
Non-sterile raw material

Assay (HPLC)
>98.0% (on dried basis)

Impurities
Total impurities 2.0%

Identification Tests
IR absorption and HPLC conform to standard

Specific Gravity
Not applicable for powder

Packing
HDPE drum or double polyethylene bags, customizable

Clindamycin Powder Api Trade Information

Minimum Order Quantity
100 Pieces

Supply Ability
100 Pieces Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Clindamycin Powder Api

Purity	99%
Grade Standard	USP
Packaging Type	Drum
Manufacturer	AVIP PHARMA
Packaging Size	25Kg
Grade	Pharma Grade
CAS Number	18323-44-9
Shelf Life	3 YEAR
Usage/Application	Treatment of Infections.
Chemical Formula	C18H33ClN2O5S
Minimum Order Quantity	25 Kg

Packaging Size	25Kg
Packaging Type	Drum
Grade	Pharma Grade
CAS Number	18323-44-9
Usage/Application	Treatment of Infections.
Chemical Formula	C18H33ClN2O5S

Clindamycin is an antibacterial medicine used for the treatment of certain serious bacterial infections.

Outstanding Purity and Quality Assurance

Clindamycin Powder API undergoes rigorous quality checks, including HPLC assay (98%) and comprehensive impurity profiling (2.0%). It is supplied with a Certificate of Analysis for each batch, ensuring transparency and reliability. The product meets strict pharmacopeial requirements (USP, EP, BP), as well as microbial and residual solvent limits.

Regulatory Compliance and Documentation

This API supports your registration needs with US DMF filing and CEP availability upon request. Detailed documentation and batch records accompany every shipment, streamlining approval processes for regulatory bodies and simplifying dossier preparation.

Versatility in Application and Packaging

Extensively used in the synthesis of clindamycin formulations for the treatment of bacterial infections, the powder is easy to handle and formulate due to its fine particle size (90% passing through 60 mesh). Packaging options are customizable, ensuring optimal transportation and storage tailored to your requirements.

FAQ's of Clindamycin Powder Api:

Q: What is Clindamycin Powder API used for?

A: Clindamycin Powder API serves as the active pharmaceutical ingredient in the synthesis of clindamycin formulations, primarily intended for the treatment of bacterial infections.

Q: How is the quality and purity of Clindamycin Powder API ensured?

A: Quality and purity are verified through identification tests (IR absorption, HPLC), an assay of 98% (HPLC, dried basis), impurity profiling (2.0% total impurities), and adherence to USP, EP, and BP standards. Every batch includes a Certificate of Analysis.

Q: When and how should Clindamycin Powder API be stored?

A: The powder should be stored in tightly closed containers, in a cool, dry, well-ventilated area, and protected from light to maintain its quality and 5-year shelf life.

Q: Where is Clindamycin Powder API manufactured and supplied from?

A: This API is manufactured, exported, and supplied by companies based in India and is available for global pharmaceutical markets.

Q: What are the packaging options for Clindamycin Powder API?

A: It is typically packed in HDPE drums or double polyethylene bags, and packaging can be customized based on specific customer requirements for secure storage and transportation.

Q: How does Clindamycin Powder API comply with regulatory requirements?

A: In addition to pharmacopeial compliance, regulatory support includes US DMF registration, CEP (upon request), and ICH-compliant testing of residual solvents and microbial limits, facilitating global market approvals.

Q: What are the benefits of using this Clindamycin API for pharmaceutical manufacturing?

A: Benefits include high purity, consistent quality, comprehensive regulatory support, customizable packaging, and suitability for a wide range of formulation processes.

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