Human Serum Albumin (HSA)

GHSA-125, 12 x 5 ml

Indications for Use

For use as a protein supplement for culture media and other solutions that are used in assisted reproductive procedures.

Storage and Shelf Life

Store at 2-8°C and protected from light. One (1) year from the date of manufacture. Do not use the product for longer than 30 days after opening the container.

Composition

HSA consists of human serum albumin from therapeutic-grad source material, as a concentration of 100 mg/ml in a sterile saline solution.

Quality Control Specifications
Paramater Specification
pH 7.2 — 7.4
Osmolality 265 — 285 mOsM
LAL Endotoxin ≤ 1.0 EU/ml
Sterility Test Sterile
1-cell Mouse Embryo Assay (% blastocysts at 96h of culture) ≥ 80%
Precautions and Warnings
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using HSA for use as a protein supplement for culture media and other solutions that are used in assisted reproductive procedures.
  3. Not to be used for injection.
  4. Do not use the product if:
    • the product packaging appears damaged or if the seal is broken
    • the expiry date has been exceeded
    • the product becomes discolored, cloudy, or shows evidence of particulate matter
  5. This product contains human serum albumin, a derivative of human blood. The human serum albumin used in the preparation of this product has been heated at 60°C for ten hours.
    Caution: All blood products should be treated as potentially infectious. Source material from which this product was derived was found negative when tested for antibodies to HIV, HBc, HCV, and HTLV I/II and non-reactive for HbsAg, HCV RNA and HIV-1 RNA and syphilis. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents.
  6. To avoid problems with contamination, practice aseptic techniques.
  7. Once the bottle is opened, store the product tightly capped at 2-8°C and protected from light. Do not use the product for longer than 30 days after opening the container.