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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
2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 1261219-83-3 C18H17NO4
Tofacitinib Impurity Tofacitinib Impurity 2504210-41-5 C29H38N10O2
tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate
2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)- 2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)- 2459302-85-1 C21H27N7O3
Avatrombopag Impurity 38 Avatrombopag Impurity 38
(1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium) (1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium) 96946-55-3 C53H72N2O12+2
9-(1,3-diacetate-2-propoxymethyl)guanine 9-(1,3-diacetate-2-propoxymethyl)guanine 86357-19-9 C13H17N5O6
Cefadroxil Impurity 6 Cefadroxil Impurity 6 2378158-45-1 C32H32N6O9S2
Loratadine Impurity 9 Loratadine Impurity 9 125743-81-9 C22H23ClN2O2
Metronidazole Impurity 1 Metronidazole Impurity 1
Parecoxib Impurity 16 Parecoxib Impurity 16 2235371-89-6 C19H18N2O4S
Rosuvastatin Impurity 54 Rosuvastatin Impurity 54
Vonoprazan Fumarate Impurity 6 Vonoprazan Fumarate Impurity 6 2250243-23-1 C33H27F2N5O4S2
3-((3aS,4R,6S,6aR)-6-(2-hydroxyethoxy)-2,2-dimethyltetrahydro- 4H-cyclopenta[d][1,3]dioxol-4-yl)-5-(propylthio)-3H-[1,2,3] triazolo[4,5-d]pyrimidin-7-ol 3-((3aS,4R,6S,6aR)-6-(2-hydroxyethoxy)-2,2-dimethyltetrahydro- 4H-cyclopenta[d][1,3]dioxol-4-yl)-5-(propylthio)-3H-[1,2,3] triazolo[4,5-d]pyrimidin-7-ol 1456538-51-4 C17H25N5O5S
Esomeprazole Impurity 24 Esomeprazole Impurity 24
Prasugrel Impurity 15 Prasugrel Impurity 15
Pregabalin Impurity 18 Pregabalin Impurity 18 1621171-19-4 C9H15NO2
Pregabalin Impurity 23 Pregabalin Impurity 23
(R)-N-Glycidylphthalimide (R)-N-Glycidylphthalimide 181140-34-1 C11H9NO3
6-chloro-N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-5- nitro-2-(propylthio)pyrimidin-4-amine 6-chloro-N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-5- nitro-2-(propylthio)pyrimidin-4-amine 1427523-93-0 C16H15ClF2N4O2S
Bendamustine Impurity 15 Bendamustine Impurity 15
Bendamustine Related Impurity 10 Bendamustine Related Impurity 10
Bortezomib Impurity 16 Bortezomib Impurity 16
Captopril Related Compound 8 Captopril Related Compound 8 112243-88-6 C9H15NO3S
Edoxaban Impurity 25 (1R,2S,4R) Oxalate Edoxaban Impurity 25 (1R,2S,4R) Oxalate
Ezetimibe Impurity 35 Ezetimibe Impurity 35 1650568-82-3 C39H46F2N2O5Si2
Fosaprepitant Impurity 8 Fosaprepitant Impurity 8
Linagliptin Impurity 28 Linagliptin Impurity 28 2074688-84-7 C22H23N7O3
Pantoprazole Impurity 3 Pantoprazole Impurity 3
Ticagrelor Related Compound 58 Ticagrelor Related Compound 58
Vildagliptin Impurity 9 Vildagliptin Impurity 9
Cefathiamidine Impurity 5 Cefathiamidine Impurity 5 40818-86-8 C10H11ClN2O4S
methyl 4-hydroxy-3,5-diisopropylbenzoic acid methyl 4-hydroxy-3,5-diisopropylbenzoic acid C14H20O3
Apixaban Impurity J Apixaban Impurity J
Avibactam Impurity C Avibactam Impurity C
Brexpiprazole Impurity M Brexpiprazole Impurity M
Cefaclor Impurity 5 Cefaclor Impurity 5
Linagliptin Impurity 39 Linagliptin Impurity 39
Peramivir Impurity 5 Peramivir Impurity 5
Pidotimod Impurity O Pidotimod Impurity O
Pramipexole EP Impurity C Pramipexole EP Impurity C
Imiquimod Impurity 5 Imiquimod Impurity 5 853793-02-9 C15H18N4
Butylphthalide impurity Butylphthalide impurity 16692-58-3 C12H14O2
ethyl 2,5-dihydroxybenzenesulfonate ethyl 2,5-dihydroxybenzenesulfonate C8H10O5S
5-ALLYLIDENE-10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTENE 5-ALLYLIDENE-10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTENE 24755-73-5 C18H16
tert-butyl (4-(benzyloxy)-8-methylnaphthalen-2-yl)carbamate tert-butyl (4-(benzyloxy)-8-methylnaphthalen-2-yl)carbamate 1662687-76-4 C23H25NO3
Nintedanib Impurity 27 Nintedanib Impurity 27
ethyl 2-(2-formyl-3-hydroxyphenyl)-4-methylthiazole-5- carboxylate ethyl 2-(2-formyl-3-hydroxyphenyl)-4-methylthiazole-5- carboxylate C14H13NO4S
LUMAT-004 LUMAT-004 313544-31-9 C16H17N3O3
Varenicline Impurity 3 Varenicline Impurity 3 1333145-89-3 C14H15N3
Econazole Related Compound C (15 mg) (1-(4-Chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium chloride) Econazole Related Compound C (15 mg) (1-(4-Chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium chloride) 57265-33-5
Amlodipine Impurity 22 (Z-Isomer) Amlodipine Impurity 22 (Z-Isomer) C26H31ClN2O8S
Amlodipine Impurity 28 Amlodipine Impurity 28 79781-21-8 C18H20ClNO5
Axitinib Impurity 16 Axitinib Impurity 16
Axitinib Impurity 22 Axitinib Impurity 22
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl- 448184-48-3 C23H32N6O5S
Dolutegravir 4-Desfluoro Impurity Dolutegravir 4-Desfluoro Impurity 1863916-87-3 C20H20FN3O5
Tetrabenazine Dehydro Impurity Tetrabenazine Dehydro Impurity 100322-43-8 C19H25NO3
Cefotiam Impurity 22 Cefotiam Impurity 22 1628441-07-5 C13H14N4O5S2
Dezocine Impurity 2 Dezocine Impurity 2 100667-17-2 C16H21NO
loteprednol Impurity 7 loteprednol Impurity 7 82034-20-6 C24H33ClO7
Sitagliptin Impurity 28 Sitagliptin Impurity 28 898543-70-9 C32H25F12N9O2
Vilanterol Impurity 3 Triphenylacetate Vilanterol Impurity 3 Triphenylacetate 503070-62-0 C23H31Cl2NO5
Empagliflozin Impurity 33 Empagliflozin Impurity 33
Sugammadex Impurity 21 Sugammadex Impurity 21 2412952-93-1 C72H113NaO48S8
4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzaldehyde trihydrochloride 4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzaldehyde trihydrochloride 1254176-45-8 C18H30N4O
Remifentanil Impurity 1 (RTF-02) Remifentanil Impurity 1 (RTF-02) 938184-94-2 C16H21N3O2
methyl (3aS,4R,6S,6aR)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3-yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate methyl (3aS,4R,6S,6aR)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3-yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate 383910-25-6 C18H30N2O5
sodium (((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy) methyl)oxidophosphoryl)-L-alaninate sodium (((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy) methyl)oxidophosphoryl)-L-alaninate 382140-24-1 C12H19N6O5P
N-Des-tetrahydrofuran N-(6,7-Dimethoxy-4,4a-dihydroquinazolin-4-amine) Alfuzosin N-Des-tetrahydrofuran N-(6,7-Dimethoxy-4,4a-dihydroquinazolin-4-amine) Alfuzosin 928780-95-4 C24H30N8O4
Zopiclone Impurity 13 Zopiclone Impurity 13
N-METHYLISATIN N-METHYLISATIN 2058-74-4 C9H7NO2
1-bromo-3-(4-ethoxybenzyl)benzene 1-bromo-3-(4-ethoxybenzyl)benzene 898538-17-5 C15H15BrO
(2S,3R,4R,5S,6R)-2-(4-chloro-3-((4-ethoxyphenyl)(methoxy) methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(4-chloro-3-((4-ethoxyphenyl)(methoxy) methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol 1318794-28-3 C22H27ClO7
Brivaracetam Impurity Brivaracetam Impurity 2432911-37-8 C11H22O3
Azithromycin EP Impurity K Azithromycin EP Impurity K
Moxifloxacin Impurity 37 Moxifloxacin Impurity 37 1803729-19-2 C7H3ClF2O2
Nimodipine  Impurity 12 Nimodipine Impurity 12 39562-18-0 C19H22N2O6
Rosuvastatin Impurity 53 Rosuvastatin Impurity 53
Evogliptin Impurity 1 Evogliptin Impurity 1
Ondansetron IMpurity 5 Ondansetron IMpurity 5
Plerixafor Impurity 1 Plerixafor Impurity 1
MeropeneM iMpurity 7 MeropeneM iMpurity 7
Afatinib Impurity 50 Afatinib Impurity 50
Brexpiprazole Impurity 34 Brexpiprazole Impurity 34 2247155-42-4 C25H27N3O4S
Cabozantinib Impurity 5 Cabozantinib Impurity 5 104330-60-1 C11H12FNO3
Dronedarone Impurity 9 Dronedarone Impurity 9
Empagliflozin Impurity 58 Empagliflozin Impurity 58
Exemestane Impurity 6 Exemestane Impurity 6 14895-71-7
Gadobutrol Impurity 10 Gadobutrol Impurity 10
Linagliptin Impurity 55 Linagliptin Impurity 55
Oseltamivir Impurity 52 Oseltamivir Impurity 52
Palbociclib Impurity 65 Palbociclib Impurity 65
Pimecrolimus Impurity 1 Pimecrolimus Impurity 1
Rosuvastatin Impurity 99 Rosuvastatin Impurity 99
Terbutaline Impurity 18 Terbutaline Impurity 18
Ticagrelor Impurity 123 Ticagrelor Impurity 123
Tofacitinib Impurity 112 Tofacitinib Impurity 112 2179757-75-4 C12H19N3O2
Trelagliptin Impurity 42 Trelagliptin Impurity 42
Carbocistein Impurity E Carbocistein Impurity E
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