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J C Boylan

Publications and source records attributed to J C Boylan.

13 recordsLinked to original sources
PubMed1983

Essential elements of quality control.

The components of quality control in the pharmaceutical industry are discussed as they apply to hospital pharmacy admixture services. The pharmaceutical industry complies with the FDA's Current Good Manufacturing Practices, which require manufacturers to have written procedures for ensuring sterility and nonpyrogenicity of injectable products. Because FDA specifies only what outcome measures must be assessed (rather than specific means of assessment), pharmaceutical companies have developed a multiplicity of quality-control systems. However, each system consists of a master formula (quantitative listing of all ingredients), master manufacturing instructions (the recipe for each product), master packaging instructions, and batch records. Documents used by quality control personnel include the specifications (identification, tests, and limits for products), test methods, and sampling procedures. Hospitals should have similar quality-control programs. These programs should systematically prevent or identify and correct deficiencies, measure overall quality, and provide information for managers. Hospital pharmacists whose departments do not have comprehensive programs should consult colleagues who have developed such procedures. Techniques used in industry should be applied when possible. To protect the integrity of manufacturers' drug products during compounding in hospitals, every hospital admixture service must have its own quality-control system.

Documentation↗
PubMed1980

Stability of frozen solutions of cefamandole nafate.

The chemical, microbiological and visual stability of frozen solutions of cefamandole nafate was studied. Solutions of cefamandole nafate were prepared by diluting 1 g of drug with 3 ml of Water for Injection, USP, or 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP (i.m. dilutions); or with 50 or 100 ml of the latter two diluents (i.v. dilutions). Stability of samples stored in glass and polyvinyl chloride plastic containers for up to 52 weeks at -10 and -20 C was measured by microbiologic, polarographic, iodometric, nephelometric and chromatographic assay and pH was measured. In mice, LD50 tests were performed using the i.m. dilutions. I.M. dilutions of cefamandole nafate were stable for 52 weeks when stored at -20 C; at -10 C, however, some samples did not freeze completely and were turbid when thawed. I.V. dilutions were stable for 26 weeks when stored at -20 C. I.V. dilutions with D5W stored at -10 C developed a transient haze. A gradual decrease in pH, which was a function of storage time, was noted for the frozen solutions. Six months of freezing did not alter the LD50 in mice. Solutions of cefamandole nafate are stable for at least 26 weeks when stored at -20 C in glass or PVC containers.

Biological Assay↗
PubMed1976

Stability of frozen solutions of cefazolin sodium.

The stability of frozen solutions of cefazolin sodium was investigated in nine commonly used diluents at concentrations of 1 g with 2.5 ml, 500 mg with 100 ml and 10 g with 45 ml in both glass and polyvinylchloride plastic containers. The diluents were: Water for Injection USP; 0.9% Sodium Chloride Injection USP; 5% Dextrose Injection USP (D5W); D5W with 0.02% sodium bicarbonate; D5W in Lactated Ringer's Injection USP; Lactated Ringer's Injection USP; Ionosol B in D5W; Normasol M in D5W; and Plasmalyte in D5W. Frozen cefazolin sodium solutions, containing Water for Injection USP, 5% Dextrose Inection USP or 0.9% Sodium Chloride Injection USP as the diluents, retained more than 90% of labeled potency for up to 26 weeks when frozen within one hour after reconstitution and held at -10 C or -20 C. Frozen cefazolin sodium solutions, made with other diluents, were stable for up to four weeks when frozen within one hour after reconstitution and held at -10 C.

Animals↗