Pharmacopeias, specifications

The U. S. Pharmacopeia specifications have been revised from time to time, becoming more specific regarding pharmaceutical characteristics. The U. S. Army specification (47), although rather loose and obsolete, is still mentioned. Both the Society of American Bacteriologists (54) and the American Public Health Association (13) have committees at work on specifications for agar suitable for use in microbiolog y. 

In 2011, Samsung Fine Chemicals acquired the technology and patents of IRE Chemicals for the production of EnPol, a biodegradable polyester resin. The IRE original resin EnPol G8000 series was based on a group of aliphatic copolyesters composed of adipic acid, succinic acid, 1,2-ethanediol and/or 1,4-butanediol [72], The producer stated that EnPol polymers met the specifications of the FDA for food contact and the United States Pharmacopeia specifications for medical device applications. 

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 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. 

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. 

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. 

Pyridine is also sold as a 1° grade, which means that the boiling poiat range of 98% of the sample will fall ia a 1°C range which iacludes the normal boiling poiat of (1) (115.3 0.1°C). Niacia (27) and niacinamide (26), equivalent forms of vitamin B, are generally sold under a US. Pharmacopeia (USP) specification (78). They are also sold as a feed-grade supplement (see Vitamins). 

Specifications. Table 10 shows the tests required to satisfy the demands of the Pharmacopeias of the United States, Europe, and Japan... 

At least six specifications of standards for granulated sugar quaUty are appHcable ia the United States. These include Codex JUimentarius Food Chemicals Codex (ECC) (4), US. Pharmacopeia (USP) and National Formula (NE) (5), National Soft Drink Association (6), National Canners Association, and Mihtary Standard-900 for white sugar. These standards are intended to set limits on various components, including, but not necessarily limited to, polarization, invert or reducing sugar, ash, moisture, color, sulfur dioxide, arsenic, lead, and copper. 

Talc sold to the cosmetics and baby powder markets must meet the Cosmetic, Toiletries and Fragrance Association (CTFA) specifications (8). For mote stringent appHcations there ate United States Pharmacopeia (USP) and Pood Codex specifications. 

Specifications for ascorbic acid, sodium ascorbate, calcium ascorbate, and ascorbyl palmitate are found in the Umted States Pharmacopeia J National Formula ... 

Specifications for niacin and niacinamide for food use are given in the Vood Chemicals Codex (63) and for pharmaceutical use in the United States Pharmacopeia (64). The Codex also gives specifications for niacinamide ascorbate. 

Nutrients and diet supplements without claims of therapeutic effects are considered foods, and are thus regulated by the U.S. Food and Dmg Administration. These are further subject to specific food regulations. Specifications for pyridoxine hydrochloride (7) for foods are given in the Food Chemicals Codex (80) and for pharmaceuticals in the US. Pharmacopeia (81). General test methods have been summarized (82). 

Specifications and standards for various vitamin E forms and preparations for use in pharmaceutical appHcations ate given in the United States Pharmacopeia (52). AH products should contain not less than 96.0% or more than 102.0% of the appropriate form. The products must be labeled to indicate both the chemical and stereochemical forms contained in the product. 

Benzaldehyde is sold as technical grade or as meeting the specifications of the NationalVormulary (NF) (7), the Vood Chemicals Codex (FCC) (8), or the British Pharmacopeia (BP) (9) (Tables 4 and 5). The test methods used for the analysis of benzaldehyde are standard methods, with the exception of the assay method. 

Table 5. British Pharmacopeia and Technical Grade Specifications ...

Benzoic acid is available in industrial and technical grades, and in grades meeting the specifications of the United States Pharmacopeia (18), the Pood Chemicals Codex (19), or the British Pharmacopeia (20). Typical specifications are Hsted in Table 5. Analytical methods required for testing to meet the specifications listed in regulatory texts are described in those texts. 

Citric acid specifications are defined in a number of compendia including Vood Chemicals Codex (FCC), United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP), and Japanese Pharmacopeia (fP). 

Both recycled and non-recycled essential oils met the standards for specific gravity, angular rotation and refractive index of the Food Chemicals Codex [22] and United States Pharmacopeia [23] for cold-pressed lemon peel oil. Results of gas chromatography analysis show the same compounds and levels in both systems, specially for the oxygenated compounds as citral (neral and geranial). Therefore, recycling the aqueous discharges to the extractor does not cause undesirable modifications. 

Excipients should be listed in the composition using their Ph Eur name (or one from another national pharmacopeia from an EEA member state), the International Nonproprietary Name, or an exact scientific designation, other than for materials such as preservatives or coloring agents which can be identified by an E-number. Third country pharmacopeial names may be acceptable. Coloring matter is subject to the provisions of specific legislation in the EEA. 

Where there are existing pharmacopeial specifications for active ingredients in the Ph Eur or the pharmacopeia of a member state, these will be expected to apply. Other pharmacopeial specifications or in-house specifications may be used in other cases. The same is true for excipients where harmonized specifications are mentioned. Particular quality requirements related to a particular application are discussed, e.g., particle size control requirements. 

USP/NF Reagents that meet the purity requirements of the U.S. Pharmacopeia (USP) and the National Formulary (NF). Generally of interest to the pharmaceutical profession, these specifications may not be adequate for reagent use. 

The European Pharmacopoeia (Ph. Eur.) has also adopted some of the apparatus designs (12) described in the USP, with some minor modifications in the specifications. Small but persistent differences between the two have their origin in the fact that the American metal processing industry, unlike the European, uses the imperial rather than the metric system. In the European Pharmacopeia, official dissolution testing apparatus for special dosage forms (medicated chewing gum, transdermal patches) have also been incorporated (Table 2 provides an overview of apparatus in Ph. Eur.). 

A pharmacopeia is a collection of recommended specifications and other information for therapeutic products, including drug substances (active ingredients), excipients, dosage forms (also called preparations), and other articles. One function of a pharmacopeia is to provide a uniform and public basis on... 

---