PARENTERAL PREPARATIONS
Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body.
Parenteral preparations may require the use of excipients, for example, to make the preparation isotonic with respect
to blood, to adjust the pH, to increase solubility, to prevent deterioration of the active substances, or to provide adequate antimicrobial properties, but not to adversely affect the intended medicinal action of the preparation or, at the concentrations used, to cause toxicity or undue local irritation.
Containers for parenteral preparations are made as far as possible from materials that are sufficiently transparent
to permit the visual inspection of the contents, except for implants and in other justified and authorized cases.
Parenteral preparations are supplied in glass containers or in other containers such as plastic containers and prefilled syringes. The tightness of the container is ensured by suitable means. Closures ensure a good seal, prevent the access of micro-organisms and other contaminants, and usually permit the withdrawal of a part or the whole of the contents without removal of the closure.
The plastic materials or elastomers used to manufacture the closures are sufficiently firm and elastic to allow the passage of a needle with the least possible shedding of particles. Closures for multidose containers are sufficiently elastic to ensure that the puncture is resealed when the needle is withdrawn.
Several categories of parenteral preparations may be distinguished :
- Injections
- Infusions
- Concentrates for injections or infusions.
- Powders for injections or infusions.
- Gels for injections
- Implants
PRODUCTION
During the development of a parenteral preparation, the formulation which contains an antimicrobial preservative, the effectiveness of the chosen preservative shall be demonstrated to the satisfaction of the competent authority.
A suitable test method together with criteria for judging the preservative properties of the formulation is provided
under Efficacy of antimicrobial preservation.
Parenteral preparations are prepared using materials and methods designed to ensure sterility and avoid the introduction of contaminants and the growth of micro-organisms. Recommendations on this aspect are
provided in the text on Methods of preparation of sterile products.
Water used in the manufacture of parenteral preparations complies with the requirements of water for injections in
bulk stated in the monograph on Water for injections.
TESTS
Particulate contamination: sub-visible particles.
For preparations for human use, solutions for infusion or solutions for injection comply with the test.
In the case of preparations for subcutaneous or intramuscular injection, higher limits may be appropriate.
Radiopharmaceutical preparations are exempt from these requirements. Preparations for which the label states that
the product is to be used with a final filter are exempt from these requirements, providing it has been demonstrated that the filter delivers a solution that complies with the test.
For preparations for veterinary use, when supplied in containers with a nominal content of more than 100 ml
and when the content is equivalent to a dose of more than 1.4 ml per kilogram of body mass, solutions for infusion or
solutions for injection comply with the test for particulate contamination: sub-visible particles.
Sterility. Parenteral preparations comply with the test for sterility.
STORAGE
In a sterile, airtight, tamper-proof container.
LABELLING
The label states:
— the name and concentration of any added antimicrobial preservative,
— where applicable, that the solution is to be used in conjunction with a final filter,
— where applicable, that the preparation is free from bacterial endotoxins or that it is pyrogenic.
http://www.uspbpep.com/ep60/parenteral%20preparations%200520e.pdf
