Product Description
Lidocaine IP Indian Pharmacopoeia Full Description
Chemical Name
2DiethylaminoN26dimethylphenylacetamide
Molecular Formula
C14H22N2O
Molecular Weight
23434 gmol
Appearance
Lidocaine appears as a white or almost white crystalline powder
Assay
Lidocaine must contain not less than 990 and not more than 1010 of C14H22N2O calculated on the anhydrous basis This ensures the purity and efficacy of the drug
Identification
Lidocaine is identified using the following methods
Infrared Absorption Spectrophotometry The infrared absorption spectrum of the sample should be concordant with the reference spectrum
Chromatographic Methods The retention time of the major peak in the chromatogram of the test solution should correspond to that in the chromatogram of the standard solution
Solubility
Soluble in water
Freely soluble in ethanol 95 and in chloroform
Practically insoluble in ether
pH
The pH of a 1 aqueous solution of lidocaine should be between 45 and 65
Loss on Drying
Lidocaine should have a loss on drying of not more than 05 indicating the amount of moisture content in the substance
Related Substances
Impurities Specific limits are set for individual and total impurities
Heavy Metals Should not exceed specified limits
Melting Point
The melting point of lidocaine should be between 66C and 70C
Specific Optical Rotation
The specific optical rotation of lidocaine should be between 010 and 010
Storage
Store lidocaine in a wellclosed container protected from light This helps in maintaining the stability and potency of the drug
Usage
Lidocaine is widely used as a local anesthetic and antiarrhythmic agent It works by blocking nerve signals in the body providing pain relief and stabilizing the hearts electrical activity in arrhythmias
This comprehensive description ensures that lidocaine meets the stringent quality standards required by the Indian Pharmacopoeia ensuring its safety and efficacy for medical use
Exceptional Quality and Standard ComplianceLidocaine IP meets stringent pharmacopeial standards (IP/BP/USP/EP), ensuring it is safe, pure, and effective for pharmaceutical use. Each batch undergoes comprehensive identification and impurity testing to guarantee compliance. Supported by a 99% minimum purity specification, manufacturers and formulators can rely on consistent product quality and stable supply.
Versatile Pharmaceutical ApplicationsWith excellent solubility in water, alcohol, and chloroform, Lidocaine IP is widely employed both as a local anesthetic and an antiarrhythmic agent. Its compatibility with most excipients enables its inclusion in topical creams, injectable solutions, and oral dosage forms, making it a preferred choice for various medical preparations.
Safe Handling and StorageLidocaine IP demonstrates stability under the recommended storage conditions and is supplied in robust HDPE carboys or fibre drums, ensuring long-term safety and integrity. It remains non-poisonous at therapeutic doses and retains efficacy for up to three years when stored as directed by the manufacturer.
FAQ's of Lidocaine IP:
Q: How should Lidocaine IP be stored to maintain its stability?
A: Store Lidocaine IP in tightly sealed fibre drums or HDPE carboys at controlled room temperature, away from moisture and direct sunlight. Under these recommended conditions, the product remains stable and effective for up to three years.
Q: What are the main pharmaceutical uses of Lidocaine IP?
A: Lidocaine IP is primarily used as a local anesthetic for minor surgical procedures and as an antiarrhythmic agent in the treatment of cardiac arrhythmias. Its high compatibility with excipients also makes it suitable for topical, injectable, and oral formulations.
Q: When is Lidocaine IP typically administered in medical settings?
A: Lidocaine IP is administered during procedures that require local anesthesia, such as dental work and minor surgeries, or when immediate control of cardiac arrhythmias is needed. The timing depends on the specific medical requirement determined by healthcare professionals.
Q: What is the process for verifying the quality of Lidocaine IP?
A: Quality is assessed through compliance with IP/BP/USP/EP pharmacopeial standards, including identification tests, impurity profiling, and checks on purity, loss on drying, and heavy metal content. These measures ensure the product meets all regulatory requirements for pharmaceutical use.
Q: Where is Lidocaine IP manufactured and how is it distributed?
A: Lidocaine IP is manufactured in India by certified manufacturers and is distributed globally to pharmaceutical companies, medical facilities, and research institutions. It is exported and supplied by trusted traders and exporters using secure packaging to maintain product integrity.
Q: What are the benefits of choosing Lidocaine IP for pharmaceutical formulation?
A: Lidocaine IP offers high purity (99%), stability, and broad excipient compatibility, ensuring reliable performance in formulations. Its safety profile at therapeutic doses and compliance with international standards make it a preferred option for medical and pharmaceutical use.
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