Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Pitavastatin Impurity 40 Pitavastatin Impurity 40
Ritonavir EP Impurity R Ritonavir EP Impurity R
Ticagrelor Impurity 68 Ticagrelor Impurity 68 1643378-46-4 C23H29FN6O4S
Tofacitinib Impurity 70 Tofacitinib Impurity 70
Afatinib Impurity 22 Afatinib Impurity 22
Amifostine Impurity 6 Amifostine Impurity 6
Apixaban Impurity 33 Apixaban Impurity 33
Aztreonam Impurity 6 Aztreonam Impurity 6
Clarithromycin Impurity EP G Clarithromycin Impurity EP G 107216-09-1 C39H72N2O13
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32
Doxofylline Impurity 7 Doxofylline Impurity 7 43135-57-5 C13H20N4O4
Erlotinib Impurity 55 Erlotinib Impurity 55
Etoposide Impurity 1 Etoposide Impurity 1
Etoposide Impurity 6 Etoposide Impurity 6
Olaparib Impurity 34 Olaparib Impurity 34
Oseltamivir Impurity 15 Oseltamivir Impurity 15 2254819-34-4 C22H36N2O4
Oseltamivir Impurity 27 Oseltamivir Impurity 27
Pitavastatin Impurity 20 Pitavastatin Impurity 20
Rocuronium Bromide Impurity 20 Rocuronium Bromide Impurity 20
Rocuronium Bromide Impurity 9 Rocuronium Bromide Impurity 9
Verapamil Impurity N Verapamil Impurity N 2086274-75-9 C33H47N3O4
Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- 478-83-1 C16H15BrN2O2
Adefovir Impurity 6 Adefovir Impurity 6
Apremilast Impurity QY Apremilast Impurity QY
Dextrorotation lansoprazole Impurity J Dextrorotation lansoprazole Impurity J
Dextrorotation lansoprazole-N-oxide Dextrorotation lansoprazole-N-oxide
lansoprazole Impurity 23 lansoprazole Impurity 23
lansoprazole Impurity 29 lansoprazole Impurity 29
Loratadine Impurity L Loratadine Impurity L C22H23ClN2O2
meta-dyhydroxy Sugammadex sodium Impurity 1 meta-dyhydroxy Sugammadex sodium Impurity 1
Olanzapine impurity R Olanzapine impurity R C17H20N4S
Palbociclib Impurity 33 Palbociclib Impurity 33
Pramipexole Related Impurity 1 Pramipexole Related Impurity 1
Ropivacaine Impurity 37 Ropivacaine Impurity 37
Ropivacaine Impurity 42 Ropivacaine Impurity 42
Sugammadex sodium Org197339-1 Impurity Sugammadex sodium Org197339-1 Impurity
Fludarabine EP impurity G Fludarabine EP impurity G 548774-56-7 C10H12ClFN5O6P
Sitagliptin Impurity 12 Sitagliptin Impurity 12 1803026-54-1 C16H12F6N4O
Afatinib impurity 30 Afatinib impurity 30
Avibactam Impurity 45 Avibactam Impurity 45 2064219-20-9 C23H46N4O6S
Butyphthalide impurity 44 Butyphthalide impurity 44 952413-01-3 C13H18O3
Cabozantinib impurity 24 Cabozantinib impurity 24
Celecoxib Impurity 18 Celecoxib Impurity 18 2271123-54-5 C11H9F3O2
Dapoxetine impurity 22 Dapoxetine impurity 22
Febuxostat Impurity 85 Febuxostat Impurity 85
Fosaprepitant Impurity NLS Fosaprepitant Impurity NLS
Irinotecan Impurity 17 HCl Irinotecan Impurity 17 HCl 1332610-75-9 C19H14N2O4
LCZ696(valsartan + sacubitril) impurity 31 LCZ696(valsartan + sacubitril) impurity 31
Lenvatinib Impurity 24 Lenvatinib Impurity 24
Lenvatinib Impurity 30 Lenvatinib Impurity 30
Regorafenib Impurity 22 Regorafenib Impurity 22
Regorafenib Impurity 28 Regorafenib Impurity 28
Sitafloxacin Impurity ZZ-C-01 Sitafloxacin Impurity ZZ-C-01
Tofacitinib Impurity 85 Tofacitinib Impurity 85 2268720-86-9 C20H24ClN5
Tofacitinib Impurity 90 Tofacitinib Impurity 90
Nintedanib Impurity M Nintedanib Impurity M
Citalopram Impurity 14 Citalopram Impurity 14 1470362-85-6 C20H23FN2O2
Eltrombopag Impurity 8 Eltrombopag Impurity 8
Vitexin 2''-O-beta-D-glucoside Vitexin 2''-O-beta-D-glucoside 61360-94-9 C27H30O15
(S)-methyl 2-(2,3-bis(hydroxymethyl)-6,7-dihydrothieno[3,2-c] pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate (S)-methyl 2-(2,3-bis(hydroxymethyl)-6,7-dihydrothieno[3,2-c] pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate 1346231-36-4 C18H20ClNO4S
Capecitabine impurity 6 Capecitabine impurity 6
Vilanterol Impurity 25 Vilanterol Impurity 25 1027529-99-2 C13H15NO4
Sugammadex sodium Org139131-1 Impurity Sugammadex sodium Org139131-1 Impurity
Dolutegravir Impurity 16 Dolutegravir Impurity 16 1357289-37-2 C20H19F2N3O5
N - hydroxy Tropisetron Impurity 2 N - hydroxy Tropisetron Impurity 2
Tofacitinib Impurity 98 Tofacitinib Impurity 98
Cabozantinib impurity 30 Cabozantinib impurity 30
Cabozantinib impurity 35 Cabozantinib impurity 35
Carvedilol Impurity DBA Carvedilol Impurity DBA 3258-70-6 C18H23NO4
Pregabalin Impurity 9 Pregabalin Impurity 9 44855-96-1 C5H7NO3
Butyphthalide impurity 50 Butyphthalide impurity 50
Canagliflozin Impurity 40 Canagliflozin Impurity 40
Pralatrexate Impurity 4 Pralatrexate Impurity 4 1445586-42-4 C18H15N5O3
Pralatrexate Impurity 9 Pralatrexate Impurity 9 1548618-61-6 C23H22N6O6
Pitavastatin Impurity 47 Pitavastatin Impurity 47
Lenvatinib Impurity 38 Lenvatinib Impurity 38
Tazobactam Impurity 9 Tazobactam Impurity 9
Doxofylline Impurity 11 Doxofylline Impurity 11 109403-76-1 C15H16N8O4
Doxofylline Impurity 14 Doxofylline Impurity 14
Canagliflozin Impurity 56 Canagliflozin Impurity 56
Canagliflozin Impurity 61 Canagliflozin Impurity 61
Tofacitinib Impurity 107 Tofacitinib Impurity 107
Hydroxychloroquine Impurity K Hydroxychloroquine Impurity K
Levosimendan Impurity 8 Levosimendan Impurity 8 274263-65-9 C14H14N6O2
Cabozantinib impurity R Cabozantinib impurity R
Rotigotine Impurity 4 Rotigotine Impurity 4
Crisaborole Impurity 4 Crisaborole Impurity 4
Crisaborole Impurity 9 Crisaborole Impurity 9
Trifluridine Impurity C Trifluridine Impurity C
Olprinone Impurity 3 Olprinone Impurity 3 1402751-73-8 C14H11N3O3
Olprinone Impurity 8 Olprinone Impurity 8
(R)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride (R)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride 117707-39-8 C17H18FN3O4
Nicorandil Impurity G Nicorandil Impurity G
Bivalirudin Impurity 3 Bivalirudin Impurity 3 1310025-28-5 C98H138N24O33
Cilastatin Impurity 3 Cilastatin Impurity 3
Solifenacin Impurity 7(Solifenacin EP Impurity D) Solifenacin Impurity 7(Solifenacin EP Impurity D) 2216750-52-4 C31H28N2O
Dyclonine Impurity 2 Dyclonine Impurity 2 66536-15-0 C13H16O2
Cefuroxime Impurity 33 Cefuroxime Impurity 33 929531-94-2 C16H16N4O9S
Ondansetron IMpurity 4 Ondansetron IMpurity 4
MeropeneM iMpurity 3 MeropeneM iMpurity 3
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