Identity of raw materials

A qualitative fingerprint check for the identity of raw material used in manufacture and for identifying drugs. 

Registration and control of identity of raw materials and their weighted amounts... 

It is very desirable to confirm the identity of raw materials and to check that they comply with specification with respect to, for example, active content, chain-length distribution or presence and nature of impurities, i.e. to make sure you are getting what you are paying for, or supplying the customer with what he is paying for. Failure to do so can and probably will cost money. 

The thermally expanded graphite was used without any preliminary treatment the carbon was synthesized by carbonation of the raw material in an argon flow at 500°C with subsequent thermal treatment. Carbon residues strongly differing in the crystallinity degree were obtained as depends on the temperature which ranged from 500°C to 1300°C. The identity of each material was checked by X-ray spectroscopy. 

The refractive index is another very rapid analytical method for determining purity and identity of a substance. It is uniquely useful for quality control monitoring of raw materials and finished products. Many students encounter a refractometer first as a universal detector for high-performance liquid chromatography. 

A major part of Taguchi s philosophy centers around the separation of effects caused by noise factors and effects caused by control factors. Control factors are variables that are under the control of the experimenter flow rate, pH, concentration, reactor temperature, etc. In contrast, noise factors are variables that are not under the control of the experimenter ambient temperature, ambient humidity, identity of process operator (Joe or Jane), source of raw material, etc. Control factors are sometimes called process factors noise factors are sometimes called environmental factors. 

Figure 14.8. The inner array exists in the three-dimensional space of control factors x X2, and X3 these might represent temperature, flow rate, and pH, respectively. The outer array is represented by the small fractional factorial designs shown at each factor combination of the inner array. It is important to understand that this inner outer does not exist in the control factor space - it exists in a separate three-dimensional space of noise factors, designated for our purposes here as z Zj, and Z3 these might represent ambient humidity, source of raw material, and identity of process operator.

The same type of model can be used to describe how the effects of the source of raw material and the identity of the process operator are in turn affected by the control factors ... 

Control analyses rely on the use of appropriate procedures or measurements assuring the identity of the materials involved in each step of the manufacturing process from receipt of raw materials to delivery of the finished products. NIR spectroscopy is an advantageous alternative to wet chemical methods and instrumental techniques such as IR, Raman and nuclear magnetic resonance (NMR) spectroscopies for positive identification. 

Transportation processes upstream of succinic acid and 1,4-butanediol are disregarded, except for sea transport of crude oil. Treatment of wastewater generated in the plant and preparation of catalysts used in production are deemed negligible factors and omitted from this evaluation. Based on data provided from the plant of Showa Denko, auxiliary materials used in production other than succinic acid and 1,4-butanediol account for a mere 0.2% of raw materials by total weight. They are omitted from this evaluation. Additionally, we do not evaluate film processing in this study, since the process is nearly identical for all products. 

Raw materials must always be approved by the Quality Unit before use by production. Each lot of raw material should be sampled and the laboratory should perform at least an identity test in addition to verifying from the supplier Certificate of Analysis (COA) that the lot test results conform to the excipient manufacturer s specification. Upon approval, the status of the lot is changed from unapproved or quarantine to approved or available. The raw material lot status can be identified by use of approval labels on the container or pallet, movement of the raw material lot to the approved section of the warehouse, or by changing the lot status in a computerized inventory system. 

NIR spectroscopy is a popular method for qualitative and quantitative analysis. It is finding widespread use in many different industries for monitoring the identity and quality of raw materials and finished products in the food, agricultural, polymer, pharmaceutical, and organic chemical manufacturing industries. 

It is probably generally desirable to include batch of raw material as one of the factors, for it may be that all batches do not react identically to particular treatments. In an example in the author s experience, a crude chemical was subjected to a purifying process, and a factorial experiment established with a... 

A statement by the manufacturer indicating that he does not produce a medicinal product with an identical formula to that of the product in his application with the exception of generic products not subjected to purchase contractual clauses of raw materials or to territorial marketing limitation ... 

Polygalaceae), Virginia (Aristolochia serpentaria, Aristolochiaceae) and white snakeroot (Eupatorium rugosum, Asteraceae). In the United States, a list of standardized common names called Herbs of Commerce (American Herbal Products Association, 1992) was adopted by the FDA as the only permitted source for common names on product labeling. Products that contain plants not listed in Herbs of Commerce are required to use the correct Latin name of the plant on the label. In addition to difficulties with nomenclature, problems have arisen because of the difficulty in determining exactly which plants are present in a finished product. Capsules that contain more than one plant and/or a dried crude extract make identification of the plant(s) by traditional means such as microscopy virtually impossible (Betz et al., 1995). Determination of the identity of a misidentified plant then becomes a matter of looking for specific toxic chemical constituents, which is usually a needle in a haystack approach unless symptoms are characteristic of a particular compound. Good quality assurance of raw material obviates the need for this detective work. 

Specification of material proof of structure, purity, proportions of impurities, identity of major impurities, stability of raw material and formulation... 

Botanical identification involves both macroscopical and microscopical inspection of the raw material. According to WHO, the macroscopical identity of plant materials is based on the shape, size, colour, surface characteristics, texture, fracture and appearance of the cut surface of leaves, herbs, seeds, fruits, barks, stolons, rhizomes and roots. Literature reports of poisonings and deaths resulting from the consumption of Digitalis collected by mistake for Comfrey (Symphytum) and of Oleander instead of Eucalyptus leaf tea highlights the importance of this simple and basic part of the quality procedure. 

The testing of raw materials before their use has three objectives confirm the identity of the raw materials, provide assurance that the quality of the drug in dosage form will not be altered by raw material defects and obtain assurance that the raw materials have the characteristics that will provide the desired quantity or yield in a given manufacturing process. 

After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity. 

Designation of raw materials or packaging materials. —Identification number of the batch and supplier s name. —Identity of the person who performed the tests or a reference permitting his identification. 

The procedures must absolutely guarantee the identity and quantities of raw materials to be used ... 

The identity and quality of a complete batch of raw materials can only be reasonably ensured if samples are withdrawn from all the containers, and not from a limited number of them taken at random according to the statistical rules applied in other industries. For this reason, samples must be taken from all the containers of a batch of raw material in order to characterize the content of each and thus render more representative the composite samples which must be taken according to the type of sampling plan adopted. An exception can be envisaged only in the case where a validated procedure has been established that gives an equivalent guarantee of the identity of the product. 

The quality control section shall check the identity, strength, quality, purity and stability of raw materials, in-process, bulk and finished products, packaging materials and shall determine their expiration dates. 

If the identity or condition of any container of raw materials or packaging materials is suspicious or does not comply with the requirements of identity or conditions, that container should be delivered to the quarantine area. The quality control unit shall then determine the disposition of the material. 

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