Reference
Common questions about sourcing pharmaceutical raw materials, and about the ingredients we supply. Written for formulators, procurement teams and anyone evaluating a raw-material supplier.
Product specifications, certificates of analysis and comparative test data are available on request. For anything not covered here, get in touch.
An active pharmaceutical ingredient is the component of a medicine that produces the intended therapeutic effect. Everything else in a tablet or capsule, such as binders, fillers, coatings and colours, is an excipient, present to make the dose stable, measurable and deliverable. A finished drug is manufactured by formulating one or more APIs together with excipients.
A manufacturer makes the material; a distributor buys, stocks and resells it; an indenting agent arranges supply between a buyer and a manufacturer without taking ownership of the goods. J. B. Khokhani & Co. works as a distributor and as an indenting agent, acting as a sourcing office for international buyers procuring from India: identifying the manufacturer, negotiating pricing, managing documentation and coordinating logistics.
At minimum: a certificate of analysis for the specific batch supplied, a material safety data sheet, and the product specification sheet stating the limits each test is judged against. For regulated markets you should also expect access to a Drug Master File where one exists, GMP compliance certificates for the manufacturing site, and documentation supporting NDA filings. Every consignment from J. B. Khokhani & Co. ships with pharmacopoeial documentation, and DMFs, NDA filing documentation, CoAs and GMP certificates are supported on request.
A Certificate of Analysis is a document recording the actual test results for one specific manufactured batch, set against the product's specification limits. It is batch-specific: a CoA for one lot says nothing about another. A useful CoA names the batch number, the manufacturing and retest dates, the test method used for each item, and the result rather than just a pass mark.
A Drug Master File is a confidential dossier submitted to a regulator describing how a material is manufactured, controlled and tested. It lets a drug manufacturer reference the ingredient supplier's process in their own filing without the supplier disclosing proprietary detail to them directly. DMFs matter most when supplying regulated markets.
They identify which pharmacopoeia's monograph the material has been tested against: IP is the Indian Pharmacopoeia, BP the British, EP the European, and USP the United States Pharmacopeia. Each publishes its own monograph for a given substance, and those monographs can differ in test methods and permitted limits, so a material meeting one is not automatically compliant with another. J. B. Khokhani & Co. supplies material to IP, BP, EP and USP grades with validated test methods.
WHO-GMP refers to the World Health Organization's Good Manufacturing Practice guidelines, which set out how pharmaceutical products must be consistently produced and controlled to quality standards appropriate to their intended use. A WHO-GMP certificate is issued to a manufacturing site by a national regulator, not to a product or a company in general. J. B. Khokhani & Co. verifies all manufacturers against GMP standards before onboarding them.
Creatine monohydrate is creatine bound to one molecule of water, and it is the most studied form of creatine in dietary supplements. Over 90% of published creatine research uses this form, it is stable as a solid, and its regulatory status is the most settled of any creatine form. Its molecular formula is C4H9N3O2·H2O, with a molecular weight of 149.15 and CAS number 6020-87-7.
Micronising reduces the particle size of the powder and instantising treats it so it wets and disperses rapidly, which together let it dissolve far faster and more completely than untreated creatine monohydrate. In practice the difference is visible in the glass: iCreatine dissolves fully in under 30 seconds when 2 g is stirred into 200 ml of room-temperature water, with a smooth mouthfeel and nothing settled at the bottom. Untreated creatine monohydrate typically dissolves slowly, needs prolonged stirring and leaves a gritty texture.
Creatinine is a degradation product of creatine that carries no nutritional value and is associated with gastrointestinal discomfort, so a lower level indicates better manufacturing quality and stability. Creatine converts to creatinine over time, particularly in aqueous solution, which is why both the specification limit and the actual batch result are worth checking. The iCreatine specification limit is ≤100 ppm.
DCD is dicyandiamide and DHT is dihydrotriazine, two process-related impurities that can carry over from creatine manufacture, and both are measured by HPLC against defined limits. They are not nutritionally useful, so a specification that states limits for them, and a batch certificate that reports the actual results, is a meaningful quality signal. The iCreatine specification sets DCD at ≤10 ppm and DHT at ≤3 ppm.
Creatine is used across four broad groups: athletes and fitness users, for faster ATP regeneration and delayed fatigue; strength and physique athletes, for muscle strength and recovery between sessions; older adults, to help preserve functional mobility and counter age-related sarcopenia; and people in cognitively demanding work, for brain energy metabolism and short-term memory under fatigue. Roughly 95% of the body's creatine stores sit in skeletal muscle.
Creatine occurs in fish and meat, but at concentrations too low to be practical as a sole source. Reaching a beneficial intake of about 5 grams a day from food alone would mean eating roughly 2.5 kilograms of meat daily, which is why supplementation is the usual route.
Related products: iCreatine® Instant Creatine Monohydrate
Vitamin K2-7, or menaquinone-7, is a form of vitamin K2 that helps bind calcium to the bone matrix and supports normal arterial function through activation of matrix Gla protein. The MenaquinGold material supplied by J. B. Khokhani & Co. is produced by fermentation using chickpeas as the substrate, and is available as powder, granules and oil at several concentrations.
Vegan vitamin D3 is cholecalciferol produced from a plant source rather than from lanolin in sheep's wool, which is how most vitamin D3 is made. The PineD3 material supplied by J. B. Khokhani & Co. is sourced from pine-tree phytosterol, is Vegan Society certified, non-GMO and allergen-free, and is available as an oil at 1,000,000 IU/g and a powder at 100,000 IU/g.
Spore-forming probiotics survive as dormant spores that resist heat, moisture and stomach acid, so they tolerate processing and storage conditions that would kill other strains; freeze-dried strains are preserved by removing water at low temperature and generally need more careful handling. The choice usually comes down to the format: spore-formers suit products facing heat or long ambient shelf lives, freeze-dried strains suit gentler formats. The J. B. Khokhani & Co. portfolio covers both across ten strains.
Related products: MenaquinGold (Natural Vitamin K2-7) · Vegan Vitamin D3 Oil · Probiotic strain portfolio
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