Serum Specifications

HUMAN SERUM PRODUCT IN HOUSE SPECIFICATIONS

pH:
7.0 – 7.4
Turbidity:
<0.240 A/546 nm after 0.2 µ filtration for non-lipid stripped material at the time of bottling at a protein <7.5 gm/dl.
<0.160 A/546 nm after 0.2 µ filtration for lipid stripped material at the time of bottling at a protein <7.5 gm/dl.
Protein:
6.0 – 6.5 gm/dl by Biuret or comparable method.
Bacteria:
<100 colony forming units/ml

BIOCHEMICAL PROFILE

Albumin:
2.5 – 5.5 gm/dl
Globulin:
1.0 – 4.0 gm/dl
SGPT (ALT):
<90 U/L
SGOT (AST):
<70 U/L
GGT:
<100 U/L
Alk. Phos.:
<120 U/L
Calcium:
<11.0 mg/dl
Phosphorus:
<4.8 mg/dl
Sodium:
120 – 160 mEq/L
Potassium:
<5.4 mEq/L
Chloride:
90 – 130 mEq/L
Cholesterol:
>100 mg/dl – non-lipid stripped<25 mg/dl – lipid stripped
Triglycerides:
>60 mg/dl – non-lipid stripped<20 mg/dl – lipid stripped
Iron:
<500 µg/dl – non-charcoal stripped<1000 µg/dl – charcoal stripped
HBsAg:
Nonreactive at the donor level.
HIV-I/II Ab:
Nonreactive at the donor level.
HCV Ab:
Nonreactive at the donor level.
STS:
Nonreactive at the donor level.
Analytes:
Analyte levels for free serum are defined as being less than the level of the sensitivity of the kit being used for the measurement. If the analyte is not less than the sensitivity amount it may still be released, pending the customer’s evaluation and acceptance, and a variance approved by Marketing, Production and Quality Control.

NORMAL ANIMAL SERUM IN HOUSE SPECIFICATIONS

Protein:>4.0 gm/dlBacteria:<100 cfu/mlpH:7.0 – 8.0

ANTIBODY PRODUCT IN-HOUSE SPECIFICATIONS

Antibody products differ greatly in their specifications due to the large variety and nature of antibody products produced. The following in-house specifications apply to all Antibody Products.

Bacteria: <100 cfu/mL

Concentration reported if liquid product