Literature: Indonesia Pharmacopoeia III,
Indonesia Pharmacopoeia IV
Imunoserum is immune globulin preparations contain typical serum obtained from animals with purification. Imunoserum has a typical strength of binding venin or toxin formed by a bacterial, or antigen binding bacteria, virus antigens or other antigens that are used for making preparations.
Imunoserum obtained from healthy animals that were immunized by injection of toxin or taksoid, venin suspension of microorganisms or other appropriate antigen. During the immunization of animals should not be given penicillin. Typical immunoglobulin containing serum obtained from immune to the precipitation fraction and treatment with enzymes or with way chemical or other physical.
Can be added antimicrobial preservatives and added the corresponding homogeneous when preparations packaged in multiple doses. Final sterile preparation can be divided aseptically in sterile containers and sealed tight to prevent contamination. Alternatively, after the preparations were distributed in sterile containers can dibekukeringkan to reduce the water content to no more than 1.0% w/w. Then the closed-tight container in a vacuum or gas filled oxygen-free nitrogen or other inert gas is suitable before it is closed tight; in each case the container is closed tight so as to eliminate contamination. Imunoserum direkonsitusi immediately before use.
Imunoserum obtained by enzyme treatment and precipitation fraction of the most stable at pH 6. Methods manufacturing imunoserum so that activity does not lose more than 5% per year when stored at pH 6 at 20º C and not more than 20% per year when stored at 37º C.
Imunoserum a liquid is almost colorless or pale yellow, not cloudy, and almost no smell except odor antimicrobial preservatives are added. Dry dosage form of solid white or pale yellow powder, readily soluble in water forming a solution of colorless or pale yellow color, and has no properties in accordance with the liquid preparation.
Imunoserum, if necessary, reconstituted as indicated on the label must meet the following requirements:
pH between 6.0 to 7.0.
Protein total no more than 17%; doing determination as set out in the determination of nitrogen in the blood product method I. The results obtained multiply by 6.25.
Albumin, except otherwise stated in the monograph, if set by electrophoresis, showed no more than imunoserum sesepora protein having the mobility of albumin
Foreign protein, if determined by precipitation test using typical imunoserum, only the protein containing strains of animals used.
Phenol, imunoserum phenol as a preservative containing not more than 0.25%, do the determination as shown in the additional material in the vaccine trials and imunoserum.
Abnormal toxicity, are eligible. Perform the test as shown in the reactivity test biology in vivo.
Sterilization, qualifies as shown in the sterility test
Protein, do a determination potential raw membandingakan to use the method as shown in each monograph.
Results are expressed in units per ml.
Containers and storage, in a container protected from light. Unless otherwise stated, liquid preparations should be stored at a temperature of 2º C to 8º C, avoid freezing.
In general imunoserum stored liquid after 3 years and the potential imunoserum stored freeze-dried after 5 years can no longer be considered equal to the potential indicated on the label.
Marking, the marking reads:
1) the minimum number of units per ml.
3) the expiration date.
4) storage conditions.
5) the volume of the reconstitution for dry powder.
6) additional material.
7) the species name of the source imunoserum.