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LABETALOL HCL IP

Name: LABETALOL HCL IP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

LABETALOL HCL IP Specification

Place of Origin
India

Particle Size
As per customer requirement

Assay
99.0% 101.0%

Molecular Weight
364.87 g/mol

Residue on Ignition
Not more than 0.1%

Loss on Drying
Not more than 0.5%

Heavy Metal (%)
Not more than 0.001%

Moisture (%)
Not more than 0.5%

Melting Point
176C 178C

Storage
Store in a cool, dry, well-ventilated area, keep container tightly closed

Molecular Formula
C19H24N2O3HCl

EINECS No
609-086-1

HS Code
29420090

Other Names
Labetalol Hydrochloride; Normodyne; Trandate

CAS No
36894-69-6

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Antihypertensive, Pharmaceutical Applications

Purity
99%

Appearance
Crystalline Powder

Application
Used as an antihypertensive agent, treatment of high blood pressure

Raw Material
Yes

Smell
Odorless

Color
White to Off-White

Form
Solid

Impurity Level
Total impurities <0.5%

Shelf Life
5 years from date of manufacture if stored properly

Therapeutic Class
Beta-blocker with alpha-blocking activity

Solubility
Soluble in water and methanol, slightly soluble in ethanol, practically insoluble in ether and chloroform

Compatibility
Compatible with most excipients used in tablet/capsule formulation

Packaging
Packed in HDPE drums or as per customer requirement

Manufacturing Standard
Manufactured under GMP conditions

Identification
Complies with IP/USP/BP standards

About LABETALOL HCL IP

Labetalol Hydrochloride (HCl), as per the Indian Pharmacopoeia (IP), is a pharmaceutical compound used primarily as a combined alpha and beta-adrenergic blocker. It is commonly prescribed for the management of hypertension, including hypertensive emergencies. The IP specifies rigorous standards and tests to ensure the quality, potency, and safety of Labetalol HCl for medicinal use.

Wide Range of Applications

Labetalol HCl IP serves primarily as an antihypertensive active ingredient, used in the formulation of pharmaceutical products for the effective treatment of high blood pressure. Thanks to its compatibility with most excipients, it is ideally suited for both tablet and capsule dosage forms.

Stringent Quality and Purity Assurance

Each batch is manufactured according to Good Manufacturing Practices (GMP), ensuring compliance with major pharmacopeial standards (IP/USP/BP). The product boasts a minimum purity of 99%, along with very low levels of impurities, heavy metals, and moisture, guaranteeing consistent therapeutic performance.

Safe and Efficient Packaging Solutions

Labetalol HCl IP is packaged in HDPE drums or tailored to specific customer requirements, ensuring the integrity of the API during transportation and storage. Proper packaging preserves quality by protecting the product from moisture, contaminants, and environmental factors.

FAQs of LABETALOL HCL IP:

Q: How should Labetalol HCl IP be stored to maintain its shelf life?

A: To ensure the full 5-year shelf life, store Labetalol HCl IP in a cool, dry, well-ventilated area and keep the container tightly closed. Proper storage prevents moisture ingress and degradation, maintaining the quality and potency of the product.

Q: What are the main pharmaceutical applications of Labetalol HCl IP?

A: Labetalol HCl IP is mainly used as an active ingredient in pharmaceutical formulations for the treatment of hypertension. Its beta- and alpha-blocking properties make it effective in managing high blood pressure, both as monotherapy and in combination with other agents.

Q: When is the ideal time to use Labetalol HCl IP in tablet or capsule manufacturing?

A: Labetalol HCl IP can be incorporated during the blending stage with excipients, as it is compatible with most substances commonly used in tablet and capsule formulations. Particle size and other processing requirements can be tailored to meet specific manufacturing protocols.

Q: Where is Labetalol HCl IP manufactured and what standards does it comply with?

A: This API is manufactured in India under strict Good Manufacturing Practices (GMP). It complies with the Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) standards, ensuring global quality acceptability.

Q: What are the solubility characteristics and how do they benefit formulation?

A: Labetalol HCl IP is soluble in water and methanol, slightly soluble in ethanol, and practically insoluble in ether and chloroform. This solubility profile facilitates its use in various pharmaceutical formulations, particularly for oral solid dosage forms.

Q: How is product safety ensured in terms of impurities and heavy metals?

A: Each lot of Labetalol HCl IP is meticulously tested to ensure total impurities are below 0.5%, residue on ignition below 0.1%, loss on drying not exceeding 0.5%, and heavy metal content under 0.001%, meeting stringent pharmaceutical-grade safety standards.

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