hahaha a bunch of unemployable losers
ended up shilling for moldovans
listen up pathetic losers
here are FDA guidelines
Pharmaceutical Quality Control Labs (7/93)
Methods can be validated in a number of ways. Methods appearing in the USP are considered validated and they are considered validated if part of an approved ANDA.
17. RAW MATERIAL TESTING
Some inspections include the coverage of the manufacturer of the drug substance. The safety and efficacy of the finished dosage form is largely dependent on the purity and quality of the bulk active drug substance. Examine the raw data reflecting the analysis of the drug substance including purity tests, charts, etc.
Check the impurity profiles of the BPC used in the biobatch and clinical production batches to determine if it is the same as that being used to manufacture full scale production batches. Determine if the manufacturer has a program to audit the certificate of analysis of the BPC, and, if so, check the results of these tests. Report findings where there is substantial difference in impurity profiles and other test results.
Some older compendial methods may not be capable of detecting impurities as necessary to enable the control of the manufacturing process, and newer methods have been developed to test these products. Such methods must be validated to ensure that they are adequate for analytical purposes in the control and validation of the BPC manufacturing process. The drug substance manufacturer must have complete knowledge of the manufacturing process and the potential impurities that may appear in the drug substance. These impurities cannot be evaluated without a suitable method and one that has been validated.
Physical tests such as particle size for raw materials, adhesion tests for patches, and extrusion tests for syringes are essential tests to assure consistent operation of the production and control system and to assure quality and efficacy. Some of these tests are filed in applications and others may be established by the protocols used to manufacture the product. The validation of methods for such tests are as important as the test for chemical attributes.
Physical properties tests often require the use of unique equipment and protocols. These tests may not be reproducible in other laboratories, therefore, on site evaluation is essential.
for you ignorant fucks, first read what a pharmacopeia is
Pharmacopoeia - Wikipedia
United States Pharmacopeia - Wikipedia
Product quality–standards and verification[edit]
USP establishes written (documentary) and physical (reference)
standards for medicines, food ingredients, dietary supplement products,
and ingredients. These standards are used by
regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist. Many other countries use the USP-NF instead of issuing their own pharmacopeia, or to supplement their government pharmacopeia.
There ARE USP entries for most human steroids
USP Monographs for Bulk Drug Substances and Other Ingredients | USP
While there is no USP monograph for boldenone
it's VALID HPLC testing method is here, written by none less than the
International Journal of Pharmacy and Pharmaceutical Sciences
http://www.ijppsjournal.com/Vol6Suppl2/6533.pdf
As you can see SIMEC should have tested for 7 related impurities A-G, they didn't
Without impurity tests, it's perfectly possible for UGLs to conceal impure raws by overdosing/overcompensating
