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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
CP-690550A CP-690550A 1243290-37-0 C15H21N5O2
(S)-Tomoxetine (S)-Tomoxetine 105314-53-2 C17H21NO
Fexofenadine EP Impurity F Fexofenadine EP Impurity F 185066-33-5 C31H37NO4
Moxidectin Moxidectin 119718-45-5 C37H53NO8
GDZISNMJFAJFMR-BEQCQUFHSA-M GDZISNMJFAJFMR-BEQCQUFHSA-M 2024603-92-5 C58H74N2O15S
GJXNGCFWGJQETE-UHFFFAOYSA-N GJXNGCFWGJQETE-UHFFFAOYSA-N 1796891-27-4 C29H34N6O4
ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate 328283-61-0 C11H11Cl2NO3
Irbesartan Impurity 4 Irbesartan Impurity 4 945540-26-1 C21H20N6O
BAUCJPGULMYPTE-UHFFFAOYSA-N BAUCJPGULMYPTE-UHFFFAOYSA-N 2097683-67-3 C24H29NO4
Entecavir Impurity 6 Entecavir Impurity 6 1354695-82-1 C26H27N5O3
Bis(L-Valine) Ester Ganciclovir TFA Salt Bis(L-Valine) Ester Ganciclovir TFA Salt 130914-71-5 C19H31N7O6
Piperacillin Impurity 4 Piperacillin Impurity 4
(R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one (R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one 2749805-70-5 C16H18F3N5O
Amlodipine Impurity 30 Amlodipine Impurity 30 95574-97-3 C4H7ClO3
Axitinib Impurity 24 Axitinib Impurity 24
Rasagiline Impurity 3 Rasagiline Impurity 3 1175018-74-2 C12H14ClN
(+/-)-EPINEPHRINE SULFONIC ACID (+/-)-EPINEPHRINE SULFONIC ACID 26405-77-6 C9H13NO5S
GADOTERIDOL   RELATED  COMPOUND   B  (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) GADOTERIDOL RELATED COMPOUND B (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) 112188-16-6 C14H22GdN4O6
4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 150727-06-3 C25H24ClN5O4S
(S)-2-(BENZYLOXY)PROPIONAL (S)-2-(BENZYLOXY)PROPIONAL 81445-44-5 C10H12O2
1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1662702-90-0 C15H15ClO
Mupirocin iMpurity F Mupirocin iMpurity F C26H44O9
Palbociclib Impurity 87 Palbociclib Impurity 87 571189-51-0 C25H31N7O2
Beclometasone Impurity U Beclometasone Impurity U
Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) 155913-31-8 C38H49NO11S
Vortioxetine Impurity 29 Vortioxetine Impurity 29 1928741-88-1 C18H23ClN2S
Neratinib Impurity 12 Neratinib Impurity 12 544417-27-8 C33H37ClN6O3
Ceftriaxone Sodium impurity 2 Ceftriaxone Sodium impurity 2
Enrofloxacin EP Impurity E Enrofloxacin EP Impurity E 1369495-59-9 C19H22ClN3O3
147027-08-5 147027-08-5 147027-08-5 C14H24O4S
Cloxacillin EP Impurity A Cloxacillin EP Impurity A 1642629-96-6 C19H20ClN3O6S
Entacapone Impurity 7 Entacapone Impurity 7 1215039-66-9 C12H10N2O6
1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride 1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride 267241-20-3 C24H37ClN4
(3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine) (3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine) C26H34F2N2O
DexMedetoMidine IMpurity 15 DexMedetoMidine IMpurity 15
Canagliflozin Impurity 1 Canagliflozin Impurity 1
Vonoprazan Impurity 24 Vonoprazan Impurity 24
Esomeprazole Impurity Esomeprazole Impurity
Esomeprazole Impurity 27 Esomeprazole Impurity 27
Amlodipine Impurity 30 Amlodipine Impurity 30 1089674-39-4 C26H31ClN2O8S
Alogliptin Impurity 30 Alogliptin Impurity 30
Orlistat Impurity 16 Orlistat Impurity 16
Olaparib Impurity 27 Olaparib Impurity 27
Hydrocortisone Impurity 14 Hydrocortisone Impurity 14 C21H30O5
Teneligliptin Impurity 5 Teneligliptin Impurity 5
Erlotinib Hydrochloride iMpurity 54 Erlotinib Hydrochloride iMpurity 54
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
Elagolix Sodium impurity4 Elagolix Sodium impurity4 2248628-92-2 C19H21NO4S
Tadalafil Impurity 45 Tadalafil Impurity 45
(R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol (R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol C28H28O3
(trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
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
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
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