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Related Concept Videos

Standard Solutions01:14

Standard Solutions

Standard solutions refer to solutions with a precisely known concentration or composition. A primary standard is a highly pure, high molar mass, stable substance that is entirely soluble in water, the most commonly used solvent in analytical chemistry. The primary standard solution can be used to standardize secondary standards, which are substances with known concentrations but are less pure and stable. Standard solutions are essential for achieving accurate and reliable results in analytical...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...

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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
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Stansardisation of sringa bhasma.

A Rajasekaran1, S Murugesan

  • 1Arulmigu Kalasalingam college of Pharmacy, Krishnankoil - 626 190.

Ancient Science of Life
|May 5, 2012
PubMed
Summary

Sringa Bhasma, an Ayurvedic medicine for asthma, underwent physico-chemical and thin-layer chromatography studies. These analyses established reliable quality control parameters for this traditional remedy.

Area of Science:

  • Ayurvedic Medicine
  • Pharmacognosy
  • Analytical Chemistry

Background:

  • Sringa Bhasma is a traditional Ayurvedic formulation primarily indicated for managing asthma.
  • Standardization of herbal medicines is crucial for ensuring their safety, efficacy, and consistency.

Purpose of the Study:

  • To establish quality control parameters for Sringa Bhasma.
  • To develop reliable analytical methods for its standardization.

Main Methods:

  • Physico-chemical analyses were performed on Sringa Bhasma samples.
  • Thin-layer chromatography (TLC) was employed for phytochemical profiling.

Main Results:

  • Key physico-chemical parameters were determined.

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  • TLC provided a characteristic fingerprint for Sringa Bhasma, aiding in identification and quality assessment.
  • Conclusions:

    • The established parameters and analytical methods can serve as dependable standards for Sringa Bhasma.
    • This standardization effort supports the consistent production and therapeutic use of this Ayurvedic medicine.