Active ingredients production volumes

Few details are available on endosulfan s production volume. In 1974, the annual production of endosulfan in the United States was estimated at 3 million pounds (Sittig 1980). However, domestic production was near 5,000 pounds in 1977 (HSDB 1999). The major U.S. manufacturer of endosulfan was FMC Corporation, formerly called the Niagara Chemical Division of Food and Machinery Corporation. FMC Corporation s annual production of endosulfan active ingredient for 1971 was estimated at about 2 million pounds (EPA 1972). According to Coleman and Dolinger (1982), however, this figure may be a low estimate. Endosulfan has not been produced in the United States since 1982 (HSDB 1999) therefore, worldwide production volumes listed after 1982 do not include data for the United States. Worldwide production of endosulfan in 1984 was estimated at 10,000 metric tons (WHO 1984). Current estimates of worldwide production or domestic formulation were not located. 

Most injections are formulated as aqueous solutions, with Water for Injections BP as the vehicle. The formulation of injections depends upon several factors, namely the aqueous solubility of the active ingredient, the dose to be employed, thermal stability of the solution, the route of injection and whether the product is to be prepared as a multidose one (i.e. with a dose or doses removed on different occasions) or in a singledose form (as the term suggests, only one dose is contained in the injection). Nowadays, most injections are prepared as single-dose forms and this is mandatory for certain routes, e.g. spinal injections such as the intrathecal route and large-volume intravenous infusions (section 2.2). Multidose injections may require the inclusion of a suitable... 

Details of time-temperature regimens as dictated by injection volume and heat transfer to the whole of the product (section 2.2) and of possible interactions between active ingredients and containers must be considered (see also Chapter 20). 

Similarly, low volume chemicals are classified according to whether they are sold primarily on the basis of specification or performance. Specialties are generally formulations that are sold on the basis of their performance and their prices reflect their value rather than cost of production. Producers of specialty chemicals often provide extensive technical service to their customers. Examples of specialty chemicals include pharmaceuticals, pesticides, flavours and fragrances, specialty polymers, etc. Fine chemicals, on the other hand, are produced to customer specifications and are often intermediates or active ingredients for specialty chemicals, e.g. pharmaceutical and agrochemical intermediates and bulk actives. 

The actual application rate should be calculated based on output, the active ingredient concentration, and the application time or land area covered. Once the plot has been treated, the amount of product or spray volume remaining should be checked as verification of the application rate. 

Moreover, the EPA Office of Pesticides and Toxic Substances has grouped pesticide active ingredients into three different categories based on production and exposure potential. One of EPA s three categories consists of "low" production pesticides. The Agency defined this category as an annual production volume of 25,000 pounds or less. 

Diluted technical grade chlordecone (80% active ingredient) was exported to Europe, particularly Germany, in great quantities from 1951 to 1975 by the Allied Chemical Company (Epstein 1978) where the diluted technical product was converted to an adduct, kelevan. Approximately 90-99% of the total volume of chlordecone produced during this time was exported to Europe, Asia, Latin America, and Africa (DHHS 1985 EPA 1978b). 

In volume-based pricing, one must be aware that the specialty-chemicals industry makes formulated products, of which the active ingredients represent only a fraction of the COGS. This is particularly the case for the pharmaceutical industry. The active ingredients of the drugs are considered as raw... 

Another important acid derived from the corresponding unsamrated acid family is the a-alkyl substituted acid (C). This compound is used in the synthesis of Aliskiren (the active ingredient of Tektuma ) which Novartis has recently been granted FDA approval as the first-in-class renin inhibitor for control of blood pressure. It is estimated that large volumes of this intermediate will be required in the future but the best ee reported so far for production of this intermediate is 95 % as shown in Figure 1.8. ... 

The first step in the production sequence is solubilizing the active ingredient in an appropriate volume of vehicle. For drug C, this blend is a solution, and the activity was routinely accomplished in the prescribed time (25 to 30 min). The analytical test results of each bulk batch confirmed that small differences in mix time had no impact. The nine receipts of active ingredient raw material used to prepare the 20 batches under review had a mean potency of 99.5%. Individual receipts ranged from 98.7-102%. No trends were noted when these receipts were examined graphically. 

To ensure good rinsing characteristics, containers should be designed to comply with the United States Environmental Protection Agency (EPA) triple rinse test or other equivalent tests for their intended formulations, i.e. the fourth rinse with one-quarter of the container s volume is to contain no more than 0.0001% of the original concentration of active ingredient in the product. 

It is also important to remember that while tissue irritation studies in laboratory animals are conducted using different chemical substances including products of cosmetics or injectable drugs, the protocol should include data on the product vehicle and at least two times the use level concentration of the active ingredient. The same volume of both preparations should be administered to all animals of the experimental groups. Observation should be made about tissue inflammation, swelling, necrosis, and other reactions. 

A specified area of filter must be soaked in a specified volume of product for a designated time. The accelerated stability of active ingredients at 40-60°C for 60 days must be established prior to the selection of a filter for a particular purpose. The extent of damage, and the nature and quantity of extractables and their potency have to be evaluated. 

Percentage weight in volume (% w/v) is the number of grams of drug in 100 mL of final product. This term is used for the concentrations of solutions, suspensions, etc. where the active ingredient is a solid for example, 5% dextrose infusion is 5 g of dextrose in 100 mL of final solution. 

Percentage volume in weight (% v/w) is the number of millilitres of drug in 100 g of final product. This usage is quite rare and is only encountered in ointments and creams where the active ingredient is a liquid, e.g. 1% glycerol ointment. 

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