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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
methyl 2,5-dihydroxybenzenesulfonate methyl 2,5-dihydroxybenzenesulfonate C7H8O5S
Pinocembroside,Pinocembrin41-O-beta-D-glucoside Pinocembroside,Pinocembrin41-O-beta-D-glucoside
4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 123441-05-4 C14H22N2O2
Dapagliflozin mono acetyl impurity Dapagliflozin mono acetyl impurity 1632287-34-3 C23H27ClO7
Piperacillin Impurity 3 Piperacillin Impurity 3
Varenicline Impurity 5 Varenicline Impurity 5 950781-87-0 C11H13N3O2
4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 30165-97-0 C6H9N3O2S
Amlodipine Impurity 29 Amlodipine Impurity 29 93848-82-9 C22H27ClN2O6
Amlodipine Impurity 34 Amlodipine Impurity 34 C26H31ClN2O8S
1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 53877-76-2 C17H24N2
propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate 1112262-71-1 C39H45FN2O5
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- 58404-37-8 C23H28O7
TYRPHOSTIN AG 1290 TYRPHOSTIN AG 1290 160391-70-8 C10H6N2O6
Palbociclib Impurity 91 Palbociclib Impurity 91 571191-15-6 C22H27N7O2
Ibrutinib Impurity 28 Ibrutinib Impurity 28 2213398-75-3 C18H15N5O
Clopidogrel Impurity 60 Clopidogrel Impurity 60 1430373-12-8 C25H26ClNO6S
Ozagrel Impurity F Ozagrel Impurity F
Ceftriaxone Sodium impurity 1 Ceftriaxone Sodium impurity 1 1214622-93-1 C10H12N2O5S
1-(2,3-EPOXYPROPYL)-2-METHYL-5-NITROIMIDAZOLE 1-(2,3-EPOXYPROPYL)-2-METHYL-5-NITROIMIDAZOLE 16773-52-7 C7H9N3O3
Bendamustine Related Impurity 12 Bendamustine Related Impurity 12
Bendamustine Related Impurity 3 Bendamustine Related Impurity 3
Lasoprazole impurity Lasoprazole impurity
2-bromo-1-(4-chlorothiophen-2-yl)ethanone 2-bromo-1-(4-chlorothiophen-2-yl)ethanone 677007-73-7 C6H4BrClOS
Fluticasone Impurity 14 Fluticasone Impurity 14 C25H31F3O5S
Ritonavir EP Impurity U Ritonavir EP Impurity U
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl
carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II)
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II) C66H68CaF2N4O10
DexMedetoMidine IMpurity O DexMedetoMidine IMpurity O
Rivaroxaban Impurity 48 Rivaroxaban Impurity 48 1414932-72-1 C21H20ClN3O4
Imatinib Impurity A Imatinib Impurity A
Vonoprazan Impurity 19 Vonoprazan Impurity 19
Pregabalin Diacid Pregabalin Diacid 1788341-42-3 C16H26N2O
Dexamethasone Impurity A Dexamethasone Impurity A
Olaparib Impurity 24 Olaparib Impurity 24
Topiroxostat Impurity 6 Topiroxostat Impurity 6
Irinotecan EP Impurity H Irinotecan EP Impurity H
Teneligliptin Impurity 4 Teneligliptin Impurity 4
Erlotinib Hydrochloride iMpurity 53 Erlotinib Hydrochloride iMpurity 53
(3R,4S)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate (3R,4S)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate 2389152-22-9 C26H24FNO5
Chemtrue-RL-N5 Chemtrue-RL-N5 1589503-97-8 C26H27F2N3O6S
Moxifloxacin EP Impurity K Moxifloxacin EP Impurity K
Anestagnate Anestagnate
Trelagliptin IMpurity 33 Trelagliptin IMpurity 33
Estradiol Impurity 1 Estradiol Impurity 1 57780-81-1 C18H24O4
Metoprolol IMpurity L Metoprolol IMpurity L C15H25NO3
Teneligliptin Impurity 14 Teneligliptin Impurity 14
Ampicillin EP Impurity P Ampicillin EP Impurity P
5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5E)- 5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5E)- 1563176-58-8 C25H34F2O5
Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester 477877-98-8 C26H40O5
1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide 1997296-62-4 C13H12F2N6O2
para-Hydroxy L-Milnacipran para-Hydroxy L-Milnacipran 688738-11-6 C15H22N2O2
Varenicline Impurity 9 Varenicline Impurity 9
Elagolix Sodium impurity3 Elagolix Sodium impurity3
Epinephrine Impurity 4 Epinephrine Impurity 4 94217-53-5 C9H13NO3
(trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 70918-74-0 C13H17ClN2O3
[4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate [4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate 41859-56-7 C22H17Cl2NO3
N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE 67669-19-6 C8H7Cl2NO2
2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 128430-66-0 C9H9ClF3NO
Edoxaban Impurity 26 (1R,2S,4R) Edoxaban Impurity 26 (1R,2S,4R) 1255529-33-9 C21H30ClN5O5
Ezetimibe Impurity 36 Ezetimibe Impurity 36 1809031-15-9 C39H46F2N2O5Si2
Linagliptin Impurity 29 Linagliptin Impurity 29 2074688-82-5 C58H58N16O6
Methylprednisolone Acetate EP Impurity H Methylprednisolone Acetate EP Impurity H 1968-76-9 C24H32O4
Rivaroxaban Impurity 44 Rivaroxaban Impurity 44
Sitafloxacin Impurity 3 Sitafloxacin Impurity 3
Tenofovir Impurity 39 Tenofovir Impurity 39
Ticagrelor Related Compound 82 Ticagrelor Related Compound 82
Vonoprazan Impurity 20 Vonoprazan Impurity 20
N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(4-methoxyphenoxy)propyl]-1-piperazineacetamide N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(4-methoxyphenoxy)propyl]-1-piperazineacetamide 1393717-45-7 C24H33N3O4
methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]
pyridin-3-yl)pyrimidin-5-yl)(ethyl)carbamate methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(ethyl)carbamate 1361570-27-5 C21H21FN8O2
Cefathiamidine Impurity G Cefathiamidine Impurity G
Olaparib Impurity P Olaparib Impurity P
Ozagrel Impurity 1 Ozagrel Impurity 1
Pidotimod Impurity P Pidotimod Impurity P
Pitavastatin Impurity 11 Pitavastatin Impurity 11
Pramipexole Impurity 18 Pramipexole Impurity 18
Tenofovir disoproxil Impurity 18 Tenofovir disoproxil Impurity 18
Tenofovir Impurity 50 Tenofovir Impurity 50
Darunavir Darunavir 1526916-57-3 C22H31N3O5S
(S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran (S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran C17H16Br2O2
Metronidazole Impurity 2 Metronidazole Impurity 2
ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5- carboxylate 144060-84-4 C17H18N2O3S
Dasatinib Impurity 24 Dasatinib Impurity 24
Pregabalin Impurity 19 Pregabalin Impurity 19 89015-27-0 C11H14O3
Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside 56316-75-7 C28H24O16
N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide 926319-54-2 C13H19NO2
Cetirizine EP Impurity B(base) Cetirizine EP Impurity B(base) 942193-17-1 C19H21ClN2O2
Dezocine Impurity 3 Dezocine Impurity 3 100667-16-1 C16H21NO2
Ertapenem Impurity 10 Ertapenem Impurity 10 357154-27-9 C22H27N3O8S
loteprednol Impurity 8 loteprednol Impurity 8 207670-54-0 C24H29ClO7
Nimodipine Impurity 4 Nimodipine Impurity 4 74936-69-9 C18H20N2O6
Paroxetine Impurity 45 Paroxetine Impurity 45 1396174-70-1 C19H20FNO3
Tazobactam Impurity 5 Tazobactam Impurity 5 115546-67-3 C21H20ClNO3S
Tigecycline Impurity 2 Tigecycline Impurity 2 1422262-97-2 C29H39N5O8
Empagliflozin Impurity 34 Empagliflozin Impurity 34
Sugammadex Impurity 22 Sugammadex Impurity 22 2412952-94-2 C72H113NaO48S8
Febuxostat Febuxostat 1312815-36-3 C20H25NO4S
Itraconazole Impurity 34 Itraconazole Impurity 34 103661-14-9 C14H15Cl2N3O5S
Lansoprazole Impurity 34 Lansoprazole Impurity 34 1357726-93-2 C7H8N2O3
Meloxicam Impurity 1 HCl Meloxicam Impurity 1 HCl 929568-25-2 C4H7ClN2O
Palonosetron Impurity 11 Palonosetron Impurity 11 2216753-67-0 C18H24N2O
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