current Good Analytical Laboratory Practices (cGALP)

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US PF 37<3> May-June 2011
 
USP general chapter <232> & <233> Elemental impurities - Limits & procedure revised to incorporate commnets revised and hormonize with ICH Q3D. To know more click Learn More & Pre-Register
 
USP general chapter - Loss on drying <732> revised to explain, how to proceed "dry to constant weight". It means "When “dry to constant weight” is specified in a monograph, drying shall be continued until two consecutive weighings do not differ by more than 0.50 mg per g of substance taken, the second weighing following an additional hour of drying (see General Notices 6.40.20).1S (USP35)
 


  • Notice of Adoption of Harmonized Standard - <905> Uniformity of Dosage Units

    Changes from the existing USP-NF General Chapter include:

    • Removed condition that allows hard capsules, uncoated tablets, and film coated tablets not meeting the 25 mg/25% requirement to be tested by the Weight variation procedure based on RSD of API concentration per dosage unit demonstrated in validation or development data. This change represents USP–specific national text and will not appear in the EP and JP.
    • Added Content Uniformity procedure and criteria for semi solid dosage forms, and instructions to assay 10 units.
The <905> Uniformity of Dosage Units General Chapter will be incorporated into and become official with the Second Supplement to USP 34–NF 29.
 
 
  • Notice of Adoption of Harmonized Standard -<711> Dissolution

    Changes from the existing USP–NF General Chapter include:
     
  • Increased the basket screen wire diameter range in Figure 1 from 0.25–0.31 mm to 0.22–0.31 mm.

The <711> Dissolution General Chapter will be incorporated into and become official with the Second Supplement to USP 34–NF 29.


Pharmacopeial Forum becomes a free, online-only publication on January 3, 2011.


   


 
 
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