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Pregabalin API Powder

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Pregabalin API Powder Specification

Ph Level
5.0-6.0 (1% solution)

HS Code
29224990

EINECS No
--

Heavy Metal (%)
0.001%

Poisonous
Non-poisonous at therapeutic doses

Melting Point
194-196C

Color
White

Shelf Life
36 months

Molecular Formula
C8H17NO2

Structural Formula
(S)-3-(aminomethyl)-5-methylhexanoic acid

Loss on Drying
0.5%

Storage
Store in a cool, dry, and well-ventilated place, protected from light

Taste
Slightly bitter

Boiling point
Not applicable / decomposes before boiling

Smell
Odorless

Particle Size
90% passes through 80 mesh

Molecular Weight
159.23 g/mol

Solubility
Freely soluble in water, sparingly soluble in ethanol

Medicine Name
Pregabalin API Powder

Chemical Name
Pregabalin

CAS No
148553-50-8

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the treatment of neuropathic pain, epilepsy, generalized anxiety disorder, and fibromyalgia

Purity(%)
>99%

Appearance
White crystalline powder

Physical Form
Solid

pH of 1% Solution
6.0-7.5

Identification
By IR and HPLC, complies with reference standard

Residual Solvents
Complies with ICH Q3C guidelines

Sulphate Content
NMT 0.05%

Optical Activity
[]D20 +8.8 (c=1, H2O)

Microbial Limits
Total aerobic microbial count NMT 100 cfu/g, total yeast & mold count NMT 10 cfu/g

Assay Method
By HPLC, not less than 99.0% and not more than 101.0% of Pregabalin

Specific Rotation
+8.5 to +9.5

Related Substances
Maximum single impurity NMT 0.1%, total impurities NMT 0.2%

Chloride Content
NMT 0.05%

About Pregabalin API Powder

Introducing our Pregabalin API Powder-an ephemeral, fresh offering at a reduced price, tailored for those with grand aspirations in pharmaceutical excellence. This noble compound is praiseworthy for its exceptional purity (>99%), minimal impurities (0.1%), and compliance with rigorous international standards. Each batch is meticulously tested for optical rotation (+10.5 to +12.5), identification (IR, HPLC), and residual solvents (within ICH limits). With a specific absorbance of 235-245, this white crystalline powder embodies reliability and safety, presented in HDPE drums and protected to maintain its integrity throughout its 36-month shelf life.

Superior Features & Versatile Application

Pregabalin API Powder stands out with an impressive >99% purity and minimal impurities, ensuring praiseworthy safety and reliability. The material is a white crystalline powder, odorless, with a slightly bitter taste, and freely soluble in water. Special features include a long 36-month shelf life and stringent microbial limits. Pregabalin is widely utilized in pharmaceuticals targeting neuropathic pain, epilepsy, generalized anxiety disorder, and fibromyalgia, making it a grand choice for manufacturers and researchers alike.

Domestic Market Focus & Sample Availability

Pregabalin API Powder enjoys a strong presence in India's main domestic market, serving as a reliable resource for retailers, suppliers, traders, and wholesalers. On arrival, product samples are available for initial assessment, fostering trust and transparency. The outlay for delivery is streamlined to ensure efficient logistics, with prompt dispatch and a reasonable charge. This approach guarantees swift availability and superior service from order to delivery, reinforcing our commitment to customer satisfaction.

FAQ's of Pregabalin API Powder:

Q: How is Pregabalin API Powder identified and tested for authenticity?

A: Pregabalin API Powder is rigorously tested using IR (Infrared Spectroscopy) and HPLC (High-Performance Liquid Chromatography) methods to confirm its authenticity and compliance with pharmaceutical standards.

Q: What are the main benefits of using Pregabalin API Powder in pharmaceuticals?

A: The API's high purity (>99%), minimal impurities, and excellent solubility in water make it ideal for consistent formulation in medications for neuropathic pain, epilepsy, anxiety disorders, and fibromyalgia.

Q: Where should Pregabalin API Powder be stored to maintain its quality?

A: For optimal preservation, store the powder in a cool, dry, and well-ventilated area, protecting it from light to ensure the full shelf life of 36 months is maintained.

Q: When can I expect delivery after placing an order for Pregabalin API Powder?

A: Once your order and sample requests are processed, we aim for prompt dispatch to ensure swift arrival, with details and delivery timelines confirmed upon order completion.

Q: What is the process for obtaining a sample of Pregabalin API Powder?

A: You can request a product sample before bulk purchase. Samples are dispatched quickly for customer evaluation, ensuring you can assess quality before committing to a larger outlay.

Q: How can Pregabalin API Powder be used in formulations?

A: Its high purity, controlled particle size, and well-documented chemical profile allow Pregabalin API to be seamlessly integrated into formulations for solid or liquid dosage forms as per regulatory requirements.

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