IVIG (High titre anti-A)

Specification

• Cat#: THP-0108-160
• Product Name: IVIG (High titre anti-A)
• Description: The passive transfer of anti-A and/or anti-B in IVIG can cause adverse reactions in recipients, including haemolysis. Therefore, there are regulatory requirements in place to control levels of these haemagglutinins. Reference preparations are available to improve international harmonisation of the testing of IVIG products, and define the pharmacopoeial limit where this applies. Preparation THP-0108-160 is an IVIG preparation with high titre haemolytic anti-A. Testing by 4 laboratories has shown that the anti-A titre of THP-0108-160 is above that of the Limit Preparation THP-0108-310, which defines the Ph. Eur. and FDA limits (titre of 64 from 5% IVIG for both anti-A and anti-B). Preparation THP-0108-160 was found to have an anti-A titre of 128-256 and an anti-B titre of 32-64 (from 5% IVIG). It is intended for use in haemolysis assays and as an out-of-specification control for anti-A in haemagglutination titrations.
• Species: Human
• Storage: Store unopened ampoules at -20 centigrade or below.
• Reconstitution: Reconstitute the ampoule contents with 1.0 mL distilled or deionised water. The reconstituted contents are 10% (w/v) IVIG.
• Usage: No attempt should be made to weigh out any portion of the freeze-dried material prior to reconstitution.