Bulk drug

PIC, 1987, Guidelines for the Manufacture of Active Pharmaceutical Ingredients (Bulk Drug Substances) (Document PH 2/87). 

The first generation process was rapidly and successfully scaled up to provide multi-ton quantities of bulk drug to adequately supply needs through phase III, drug filing and launch. 

Chander Mohan was born in 1975 at Dhariwal, Punjab, India. He received his B.Pharm. and M.Tech.(Pharm.) in bulk drugs from Guru Nanak Dev University and the National Institute of Pharmaceutical Education and Research (NIPER), Mohali. After that he worked as senior chemist at Dr. Reddy s Research Foundation, Hyderabad. He then joined Professor M. P. Mahajan s research group in 2002 for his doctoral studies. His research is focused on the synthesis and chemical transformation of C-5/C-6-substituted pyrimidinones. His research interests include synthesis of medicinally important molecules, transition metal-induced transformations in organic synthesis, reaction mechanism and total synthesis of natural products. 

HPLC methods have been widely used for the analysis of OTC in different samples. As described above in the Section 2.3, the HPLC method is described in most of compendia [1,2,4,7] for determination of OTC in bulk drug substances and in some pharmaceutical preparations. The application of HPLC methods for the analysis of antibiotics including oxytetracycline has been recently reviewed by Diaz-Cruz et al. [37] and Lunn [38], A summary of HPLC method for the analysis of OTC is presented in Table 3. 

Silica gel treated with EDTA/NaOH CH2Cl2-MeOH-Water (58 35 7) UV 365 nm Bulk drug... 

Vollmer et al. [4] compared the Hg(II) acetate method described in the Code of Federal Regulations for the determination of penicillamine in bulk drug and formulations with (i) a nonaqueous lithium methoxide titration, (ii) a nonaqueous HCLO4 titration, and (iii) a colorimetric method with hydroxylamine. Method (ii) was unsatisfactory for bulk determinations. Method (i) was less precise than the Hg(II) acetate method, but gave satisfactory results for bulk drug and capsule samples. Method (iii) was the only method that gave satisfactory results in the presence of EDTA. 

GMP bulk drug synthesis, including stability studies... 

As the maturity of the process increased, only the key parameters would require continued monitoring. Ultimately, the data collected on these properties would permit the generation of material specifications. If the work had been performed properly, then it would be possible to specify limits for the-appropriate bulk drugs and raw materials that would ensure that the final product always was satisfactory. These guidelines would naturally apply only to the specific formulation, but their implementation would enable manufacturers to deliver their products with a greater degree of security than is now possible. 

Most chemists tend to think of infrared (IR) spectroscopy as the only form of vibrational analysis for a molecular entity. In this framework, IR is typically used as an identification assay for various intermediates and final bulk drug products, and also as a quantitative technique for solution-phase studies. Full vibrational analysis of a molecule must also include Raman spectroscopy. Although IR and Raman spectroscopy are complementary techniques, widespread use of the Raman technique in pharmaceutical investigations has been limited. Before the advent of Fourier transform techniques and lasers, experimental difficulties limited the use of Raman spectroscopy. Over the last 20 years a renaissance of the Raman technique has been seen, however, due mainly to instrumentation development. 

Bulk drug 13C, 31P, 1SN, 25Mg, 23Na Solid state structure elucidation, drug-excipient interaction studies (variable temperature), (pseudo)polymorphic characterization at the qualitative and quantitative level, investigation of hydrogen bonding with salt compounds... 

Powder flow is most frequently thought of as relevant to formulation development, and there are numerous references attempting to correlate any one of a number of measures of powder flow to the manufacturing properties of a formulation [34—40]. In particular, the importance of physical properties in affecting powder flow has been well documented. Research into the effect of the mechanical properties on powder flow has, however, been very limited. It is, of course, important to be able to determine and quantitate the powder flow properties of formulations. It is of equal importance, however, to determine the powder flow characteristics of bulk drug early in the development process (preformulation phase). Often, the preformulation or formulation scientist is constrained by time, materials, and manpower. Yet certainly the preformulation studies carried out should be meaningful. Well-defined experimental methods and procedures should be used the information generated should be reproducible and permit useful predictions to be made. 

Lot to lot variations in excipients and bulk drugs are seen in Tables 4 and 5. The ibuprofen lots in Table 5 represent three lots specially recrystallized to... 

Table 7 Ibuprofen Bulk Drug Regression Analysis for the Dependent Variable Shear Index, n...

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