Pharmacopeias

Note USP code is the United States Pharmacopeia designation. 

Bacterial Endotoxias Test (85)," "Biological Reactivity Tests, in vivo (88)," "Particulate Matter ia Injections (788)," and "Purified Water," JJSP 23 The U.S. Pharmacopeia Convention, RockviUe, Md., 1994. 

The United States Pharmacopeia, 21st rev. The NationalTormulary, 16th ed.. United States Pharmacopeia Convention, RockviUe, Md., 1984 Tood Chemicals Codex, 3rd ed.. National Academy Press, Washington, D.C., 1981. 

Quality Control. Because fine chemicals are sold according to specifications, adherence to constant and strict specifications, at risk because of the batchwise production and the use of the same equipment for different products ia multipurpose plants, is a necessity for fine chemical companies. For the majority of the fine chemicals, the degree of attention devoted to quahty control (qv) is not at the discretion of the iadividual company. This is particularly the case for fine chemicals used as active iagredients ia dmgs and foodstuffs (see Fine chemicals, standards). Standards for dmgs are pubHshed ia the United States Pharmacopeia (USP) ia the United States (6) and the European Pharmacopeia ia Europe (7). 

The Ended States Pharmacopoeia XXI (ESP XXII-NF XVII), The United States Pharmacopeia Convention, Inc., Rockville, Md., 1990. 

United States Pharmacopeia. Reference standards are requited in many USP and NF tests, and in a few FCC tests. The USPC distributes such standards domestically and has authorized international distribution by a number of organizations or companies. There are well over 1000 USP Reference Standards, including several for melting points, and also specimens of narcotics and other controlled substances. New standards are constantly under development as needed in various USP, NF, and FCC testing methods. 

The JnitedSfates Pharmacopeia (76) specifications for sodium monofluorophosphate require a minimum of 12.1% fluoride as PO F (theoretical 13.2%) and a maximum of 1.2% fluoride ion reflecting unreacted sodium fluoride. Analysis for PO F is by difference between total fluoride ia the product less fluoride ion as determined by a specific ion electrode. The oral LD q of sodium monofluorophosphate ia rats is 888 mg/kg. 

The United States Pharmacopeia, Twenty-Second Kevision, The United States Pharmacopeia Convention Inc., RockviUe, Md., 1989. 

Specifications for hGH products are defined by the governmental licensing authorities, eg, the U.S. Pood and Dmg Administration. Draft monographs for hGH have been prepared by both the EnitedStates Pharmacopia and the European Pharmacopeia commissions and should be formally adopted by 1995. These specifications are suitable for biosynthetic hGH. The much less purified pituitary-derived hGH has virtually disappeared from commercial production. An international reference standard for pituitary-derived hGH (lot 80/505) has been used for caUbration, particularly for bioassay purposes. A highly purified biosynthetic hGH standard (lot 88/624) has been prepared and should be formally adopted by 1995, or before. 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

Committee of Revision, Eecithin, Fhe Ended States Pharmacopeia U.S. Pharmacopeial Convention, RockviUe, Md., 1990, p. 1572. 

U.S. Pharmacopeia XXII and National Formulay XTTI, U.S. Pharmacopeial Conventions, Inc., Washington, D.C., 1990. 

The CnitedSfates Pharmacopeia (USP) and the Hationa/Pormu/aTy (NP) ate the recognized standards for potency and purity for most common dmg products. The USP was first pubflshed in 1833 the NP in 1887. Upon adoption of the first Pood and Dmg Act in 1906 these compendia became official, ie, they pubflsh the legal standards of quaUty, purity, and strength. The 1980 editions of USP(XX) and NP(XV) were combined for the first time revisions take place every five years. USPXXIII/NFXVIII is effective as of 1995. 

The US. Pharmacopeia (USP) specification for phenol includes (/) purity is to be no less than 98 wt %, (2) clear solubiUty of 1 part of phenol in 15 parts of water, (2) a congealing temperature to be not lower than 39°C, and (4) a content of nonvolatiles of no more than 0.05 wt %. Commercially, phenol specifications far exceed the USP requirement. Typical commercial phenol specifications are Hsted in Table 5. Higher purity material is required for some apphcations. 

United States Pharmacopeia NationalFormulay, 22nd ed.. Mack Publishing, Easton, Pa., 1990, p. 50. 

United States Pharmacopeia stronger ammonia water ammonia test solution normal (1 N) aqua ammonia chemically pure technical, Bh°... 

United States Pharmacopeia XXII-NationalFormulary XTTI, 1990. 

The British Pharmacopoeia specifies a biological assay for the sodium salt of rifamycia SV [14897-39-3]. It also specifies a spectrophotometric assay for rifampicia (201). The United States Pharmacopeia requires an hplc assay for rifampin (202). 

Values of acidity, nonvolatility, and refractive index for 1990 US. Pharmacopeia XXII a2eotropic (91—93 vol %) isopropyl alcohol are equal to those of 1990 USP XXII anhydrous. 

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