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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
Aciclovir EP Impurity N Aciclovir EP Impurity N
Vonoprazan Impurity U2 Vonoprazan Impurity U2
Parecoxib SodiuM iMpurity 36 Parecoxib SodiuM iMpurity 36
phenyl (3R,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate compound phenyl (3R,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate compound 105812-85-9 C26H24FNO5
Apixaban Impurity A25 Apixaban Impurity A25
Trelagliptin IMpurity 32 Trelagliptin IMpurity 32
Afatinib Impurity 77 Afatinib Impurity 77 26404-20-6 C5H7ClO3
2a,3a,16a,17a-Diepoxy-17b-acetoxy-5a-androstane 2a,3a,16a,17a-Diepoxy-17b-acetoxy-5a-androstane 50588-22-2 C21H30O4
bis(6-(((3S,4R)-4-(4-fluorophenyl)piperidin-3-yl)methoxy)benzo[d][1,3]dioxol-5-yl)methane bis(6-(((3S,4R)-4-(4-fluorophenyl)piperidin-3-yl)methoxy)benzo[d][1,3]dioxol-5-yl)methane 2105932-71-4 C39H40F2N2O6
Tenofovir Impurity 60 Tenofovir Impurity 60
((3R,4S)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate ((3R,4S)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate 1258537-32-4 C20H24FNO3S
Mupirocin Calcium EP Impurity H Mupirocin Calcium EP Impurity H C26H44CaO9
Tricyclo[3.3.1.13,7]decane-1,3-diol, 5-amino- Tricyclo[3.3.1.13,7]decane-1,3-diol, 5-amino- 1382839-19-1 C10H17NO2
(trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- methoxyphenyl)piperidine-1-carboxylate (trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- methoxyphenyl)piperidine-1-carboxylate C27H27NO6
Org198786-1 Org198786-1 2412952-96-4 C71H114NNaO46S7
2-Thiazolamine, 4-(4-bromo-2-thienyl)- 2-Thiazolamine, 4-(4-bromo-2-thienyl)- 81216-89-9 C7H5BrN2S2
Enrofloxacin EP Impurity C Enrofloxacin EP Impurity C 138892-82-7 C19H23N3O3
Pregabalin Lactam (S)-Isomer Lactose Adduct Pregabalin Lactam (S)-Isomer Lactose Adduct 466678-44-4 C20H35NO11
Ertapenem Impurity Pro-maba Ertapenem Impurity Pro-maba 724700-26-9 C12H14N2O3
Empagliflozin Impurity 22 Empagliflozin Impurity 22
Empagliflozin Impurity 35 Empagliflozin Impurity 35 1459754-40-5 C13H8ClIO2
tirofiban tirofiban 464175-13-1 C9H18ClN
1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-4,11-difluoroacetyl-1,4,8,11- tetraazacyclotetradecane 1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-4,11-difluoroacetyl-1,4,8,11- tetraazacyclotetradecane
Fulvestrant Impurity 4 Fulvestrant Impurity 4 1621885-82-2 C30H44O6S
Clopidogrel Clopidogrel 1360923-54-1 C16H16ClNO3S
Ozagrel-015 Ozagrel-015 1332370-00-9 C10H10O3
Piperacillin Sulfoxide Piperacillin Sulfoxide 67275-27-8 C23H27N5O8S
Budesonide Impurity 11 Budesonide Impurity 11 39672-76-9 C21H26O5
1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl) benzyl)-1,4,8,11-tetraazacyclotetradecane dodecahydrochloride 1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl) benzyl)-1,4,8,11-tetraazacyclotetradecane dodecahydrochloride 2173049-85-7 C46H85ClN12
Mirabegron Impurity 26 Mirabegron Impurity 26 91828-74-9 C8H9N3O4
Alosetron Impurity 1 Alosetron Impurity 1 1011293-30-3 C17H16N4O2
2-(3-cyano-4-isobutoxyphenyl)-N,N,4-trimethylthiazole-5- carboxamide 2-(3-cyano-4-isobutoxyphenyl)-N,N,4-trimethylthiazole-5- carboxamide 1380049-45-5 C18H21N3O2S
Acarbose Impurity F Acarbose Impurity F
Oseltamivir  Impurity 10 Oseltamivir Impurity 10 2081110-43-0 C16H28N2O4
Pitavastatin Impurity 41 Pitavastatin Impurity 41
Rivaroxaban Impurity 14 Rivaroxaban Impurity 14 1429334-02-0 C15H21N3O4
Ticagrelor Impurity 69 Ticagrelor Impurity 69
Tofacitinib Impurity 71 Tofacitinib Impurity 71
Tofacitinib Impurity 79 Tofacitinib Impurity 79
Topiroxostat Impurity 5 Topiroxostat Impurity 5 2050015-91-1 C7H6N4O
Canagliflozin-10 Canagliflozin-10 2161394-94-9 C24H25FO5S
2-amino-N-(2-methylphenyl)-5-thiazolecarboxamide 2-amino-N-(2-methylphenyl)-5-thiazolecarboxamide 1184914-03-1 C11H11N3OS
Afatinib Impurity 23 Afatinib Impurity 23 1314777-66-6 C8H4FN3O3
Atracurium Impurity 25 Atracurium Impurity 25 86682-55-5 C20H25NO5
Aztreonam Impurity 7 Aztreonam Impurity 7
Canagliflozin Impurity 43 Canagliflozin Impurity 43
Carvedilol Impurity 2 Carvedilol Impurity 2 1198090-71-9 C18H17NO3
Clotrimazole Impurity 2 Clotrimazole Impurity 2
Dapagliflozin Impurity 33 Dapagliflozin Impurity 33
Erlotinib Impurity 56 Erlotinib Impurity 56
Moxifloxacin Impurity 8 Moxifloxacin Impurity 8 1829588-19-3 C21H25N3O5
Olaparib Impurity 30 Olaparib Impurity 30 1460272-52-9 C24H21FN4O4
Pitavastatin Impurity 27 Pitavastatin Impurity 27
Pramipexole Impurity 24 Pramipexole Impurity 24
Rocuronium Bromide Impurity 22 Rocuronium Bromide Impurity 22
Tolterodine Impurity 1 Tolterodine Impurity 1 88407-28-7 C22H31NO
Voriconazole Impurity 7 Voriconazole Impurity 7 239807-04-6 C16H14F3N5O
Apremilast Impurity SJM Apremilast Impurity SJM
Aprepitant Impurity 28 Aprepitant Impurity 28
AZD9291 Osimertinib Impurity 3 AZD9291 Osimertinib Impurity 3
Dextrorotation lansoprazole Impurity K Dextrorotation lansoprazole Impurity K
Doxofylline Impurity A Doxofylline Impurity A
lansoprazole Impurity 24 lansoprazole Impurity 24
lansoprazole Impurity 30 lansoprazole Impurity 30
meta-dyhydroxy Sugammadex sodium Impurity 2 meta-dyhydroxy Sugammadex sodium Impurity 2
Palbociclib Impurity 29 Palbociclib Impurity 29
Palbociclib Impurity 34 Palbociclib Impurity 34
Ropivacaine Impurity 38 Ropivacaine Impurity 38
Ropivacaine Impurity 43 Ropivacaine Impurity 43 2726971-51-1
Sugammadex sodium Decomposition process Impurity 1 Sugammadex sodium Decomposition process Impurity 1
Sugammadex sodium Org198786-1 Impurity Sugammadex sodium Org198786-1 Impurity
Sugammadex sodium starting material Impurity 1 Sugammadex sodium starting material Impurity 1
Fludarabine EP impurity H Fludarabine EP impurity H 548774-57-8 C10H10FN5O3
Afatinib impurity 31 Afatinib impurity 31
Butyphthalide impurity 30 Butyphthalide impurity 30
Cabozantinib impurity S Cabozantinib impurity S
Canagliflozin Isomer Impurity 1 Canagliflozin Isomer Impurity 1
Celecoxib Impurity 19 Celecoxib Impurity 19 C17H14F3N3O2S
Febuxostat Impurity 81 Febuxostat Impurity 81
Gefitinib Impurity Q Gefitinib Impurity Q
Irinotecan Impurity 20 HCl Irinotecan Impurity 20 HCl 870527-52-9 C20H20N2O4
LCZ696(valsartan + sacubitril) impurity 32 LCZ696(valsartan + sacubitril) impurity 32
Lenvatinib Impurity 25 Lenvatinib Impurity 25
Leosimendan azide Impurity Leosimendan azide Impurity
Regorafenib Impurity 23 Regorafenib Impurity 23 3083426-63-2
Regorafenib Impurity 31 Regorafenib Impurity 31
Sitafloxacin Impurity XT-D-01 Sitafloxacin Impurity XT-D-01
Sitafloxacin Impurity ZZ-E-01 Sitafloxacin Impurity ZZ-E-01
Tofacitinib Impurity 86 Tofacitinib Impurity 86
Tofacitinib Impurity 91 Tofacitinib Impurity 91
Gefitinib impurity N Gefitinib impurity N
Docetaxel Impurity 24 Docetaxel Impurity 24 1217248-58-2 C29H34O9
Olopatadine Impurity 2 Olopatadine Impurity 2 56427-76-0 C19H18O4
Pitavastatin Impurity 24 Sodium Salt Pitavastatin Impurity 24 Sodium Salt 1980814-90-1 C25H24FNO6
(3S,5S)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate (3S,5S)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate 1428118-12-0 C37H43FN2O5
2-Hydroxy-3-(pyridin-3-yl)pyridine 2-Hydroxy-3-(pyridin-3-yl)pyridine 82407-65-6 C10H8N2O
2-Hydroxy-5-(4-pyridyl)pyridine 2-Hydroxy-5-(4-pyridyl)pyridine 62749-34-2 C10H8N2O
Ibubinib impurity Ibubinib impurity
Amoxicillin EP Impurity K Amoxicillin EP Impurity K C16H19N3O5S
Amoxicillin EP Impurity C Amoxicillin EP Impurity C 2088961-37-7 C16H19N3O5S
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