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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
Rosuvastatin Impurity 161 Rosuvastatin Impurity 161
Rosuvastatin Impurity 155 Rosuvastatin Impurity 155
Rosuvastatin Impurity 146 Rosuvastatin Impurity 146
Rosuvastatin Impurity 126 Rosuvastatin Impurity 126
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate 29461-90-3 C18H21NO3S2
Digoxin Impurity 2 Digoxin Impurity 2
DUTP, 100MM SOLUTION DUTP, 100MM SOLUTION 94736-09-1 C9H16N2NaO14P3
Oxacillin USP Impurity D Oxacillin USP Impurity D
Oxacillin sodium EP impurity B Oxacillin sodium EP impurity B
Ceftazidime Impurity IMPA Ceftazidime Impurity IMPA
Pitavastatin Impurity 82 Pitavastatin Impurity 82
Terbutaline EP Impurity B Complete Set Terbutaline EP Impurity B Complete Set
Peramivir Intermediate impurity 2 Peramivir Intermediate impurity 2
Cetrorelix Impurity 8 (+L-Pro) Cetrorelix Impurity 8 (+L-Pro)
Peramivir Intermediate Impurity 44 Peramivir Intermediate Impurity 44
Peramivir Hydroxy Isomeric Impurity Peramivir Hydroxy Isomeric Impurity
Nintedanib impurity F drops Nintedanib impurity F drops
Favipiravir Impurities 1-19 Favipiravir Impurities 1-19
2-Desisopropyl-2-phenyl Repaglinide 2-Desisopropyl-2-phenyl Repaglinide 107362-12-9 C30H34N2O4
2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE 2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE 114444-10-9 C14H9ClN2O
Droxidopa Impurity M Droxidopa Impurity M
Vigabatrin Impurity 2 Vigabatrin Impurity 2
Aripiprazole peroxide degradation Impurity (MW:464Da) Aripiprazole peroxide degradation Impurity (MW:464Da)
Zileuton Impurity (MW = 279.31 Da) Zileuton Impurity (MW = 279.31 Da)
3'-chloro-3'-deoxythymidine (zidovudine impurity) 3'-chloro-3'-deoxythymidine (zidovudine impurity)
Rivaroxaban Impurity 81 Rivaroxaban Impurity 81
Salbutamol Impurity 37 Salbutamol Impurity 37
Gadobutrol Impurity 21 Gadobutrol Impurity 21
Flucloxacillin sodium EP Impurity E Flucloxacillin sodium EP Impurity E
Pyrazole Pyrazole
Cephalomannine (Paclitaxel Impurity I) Cephalomannine (Paclitaxel Impurity I)
Aristolactam IIIa N-β-glucoside Aristolactam IIIa N-β-glucoside 80311-26-8 C22H19NO9
METOPROLOL IMPURITY D METOPROLOL IMPURITY D C15H25NO3
NITRENDIPINE IMPURITY A NITRENDIPINE IMPURITY A
TAMSULOSIN IMPURITY D TAMSULOSIN IMPURITY D C20H28N2O5S
Macitentan Hydroxy amine Impurity Macitentan Hydroxy amine Impurity 2211059-05-9 C12H12BrN3O2
2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl- 2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl- 2276323-24-9 C10H16N4O2
7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester 7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester 7029-96-1 C11H14N4O4
PANTOPRAZOLE N-OXIDE PANTOPRAZOLE N-OXIDE 953787-60-5 C16H15F2N3O5S
DEHYDROARIPIPRAZOLE, HYDROCHLORIDE DEHYDROARIPIPRAZOLE, HYDROCHLORIDE 1008531-60-9 C23H26Cl3N3O2
N-(3-GUANIDINO-4-METHYLPHENYL)-4-(METHYLPIPERAZINE-1-YL-METHYL)BENZAMIDE N-(3-GUANIDINO-4-METHYLPHENYL)-4-(METHYLPIPERAZINE-1-YL-METHYL)BENZAMIDE 581076-65-5 C21H28N6O
Tirofiban-d9 Hydrochloride Tirofiban-d9 Hydrochloride 1331911-68-2 C22H37ClN2O5S
2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 115538-83-5 C11H14ClNO3
Ibuprofen Alcohol Ibuprofen Alcohol 36039-36-8 C13H20O
Ticagrelor Impurity 138X Ticagrelor Impurity 138X
Apremilast Impurity 999 Apremilast Impurity 999
Pranoprofen Impurity C Pranoprofen Impurity C
isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine
(S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid (S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid
3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 2755812-41-8 C23H32F3N5O4
3-(4-cyanophenoxy)benzyl acetate 3-(4-cyanophenoxy)benzyl acetate 2990481-66-6
5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide 5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide 2948773-23-5
Bisoprolol Impurity 53 Bisoprolol Impurity 53
Nintedanib Impurity 26 Nintedanib Impurity 26
N-Formyl impurity N-Formyl impurity
(3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine (3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine 2227197-38-6 C14H21N5
Varenicline Impurity 1 Varenicline Impurity 1
Amlodipine Impurity 27 Disodium Salt Amlodipine Impurity 27 Disodium Salt 120289-11-4 C19H20ClNO7
Erlotinib Impurity 47 HCl Erlotinib Impurity 47 HCl
Etoricoxib Impurity 33 Etoricoxib Impurity 33
2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 18823-63-7 C10H11Cl2NO
2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 93413-76-4 C15H19NO2
4,5-Dibromo-1,2-benzenediol 4,5-Dibromo-1,2-benzenediol 2563-26-0 C6H4Br2O2
CLOPIDOGREL CARBOXYLIC ACID CLOPIDOGREL CARBOXYLIC ACID 144457-28-3 C15H14ClNO2S
RAC (CIS/TRANS) DONEPEZIL N-OXIDE RAC (CIS/TRANS) DONEPEZIL N-OXIDE 120013-84-5 C24H29NO4
5-Carboxy-2'-deoxyuridine 5-Carboxy-2'-deoxyuridine 14599-46-3 C10H12N2O7
BENZENE ACETIC ACID, 4-[(2-CARBOXYPHENYL)METHOXY] BENZENE ACETIC ACID, 4-[(2-CARBOXYPHENYL)METHOXY] 55453-89-9 C16H14O5
Ipragliflozin Impurity 5 Ipragliflozin Impurity 5
Alectinib Impurity Alectinib Impurity 1256584-83-4 C26H25N3O2
Afatinib impurity 11/Des-(4-dimethylamino-2-en-1-oxo)butylamino 6-(5-Hydroxy-pyrrolidin-2-on-1-yl) Afatinib Afatinib impurity 11/Des-(4-dimethylamino-2-en-1-oxo)butylamino 6-(5-Hydroxy-pyrrolidin-2-on-1-yl) Afatinib 2223677-58-3 C22H20ClFN4O4
Ibrutinib Impurity 18 Ibrutinib Impurity 18 1881246-01-0 C16H12N4O
ERYTHROMYCIN IMPURITY N ERYTHROMYCIN IMPURITY N
Fesoterodine Impurity 12 Fesoterodine Impurity 12
Dexamethasone EP impurities D Dexamethasone EP impurities D
Palbociclib impurity LMAP Palbociclib impurity LMAP
(3R,3'R)-3,3'-((((S)-1-amino-1-oxobutan-2-yl)azanediyl)bis(methylene))dihexanoic acid (3R,3'R)-3,3'-((((S)-1-amino-1-oxobutan-2-yl)azanediyl)bis(methylene))dihexanoic acid C18H34N2O5
Acetaminophen EP Impurity L Acetaminophen EP Impurity L C8H9NO2
Anagrelide Impurity 2 HCl Anagrelide Impurity 2 HCl
Mizolastine Impurity N Mizolastine Impurity N 108612-60-8 C25H27FN6O
(R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol (R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol 317351-40-9 C16H19NO3
N,N'-Bis(4-hydroxyphenyl)hydrazine N,N'-Bis(4-hydroxyphenyl)hydrazine 158905-63-6 C12H12N2O2
1,3-diethyl-1,3-dimethylurea 1,3-diethyl-1,3-dimethylurea 31468-19-6 C7H16N2O
N-(2-Amino-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acrylamide N-(2-Amino-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acrylamide
Rifampin Impurity 6 Rifampin Impurity 6
Cefuroxime Dioxide Impurity(Cefuroxime Sulfoxide) Cefuroxime Dioxide Impurity(Cefuroxime Sulfoxide)
Amoxicillin Impurity N(EP) Amoxicillin Impurity N(EP)
Ampicillin Impurity F(USP) Ampicillin Impurity F(USP)
Azlocillin Opern-Ring Acetylation Impurity Azlocillin Opern-Ring Acetylation Impurity
Miconazole Impurity G(EP) Miconazole Impurity G(EP) 1370335-40-2 C18H14Cl4N2O
2-chloro-1-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one 2-chloro-1-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
2-(5H-chromeno[2,3-b]pyridin-7-yl)acrylic acid 2-(5H-chromeno[2,3-b]pyridin-7-yl)acrylic acid 52549-22-1 C15H11NO3
1-(6-chloro-5-fluoropyrimidin-4-yl)ethanol 1-(6-chloro-5-fluoropyrimidin-4-yl)ethanol 1289559-76-7 C6H6ClFN2O
Fluoxetine Impurity 29,methyl({3-phenyl-3-[2-(trifluoromethyl)phenoxy]propyl})amine Fluoxetine Impurity 29,methyl({3-phenyl-3-[2-(trifluoromethyl)phenoxy]propyl})amine 56161-71-8 C17H18F3NO
(Z)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine (Z)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Ceftriaxone sodium impurity 09 Ceftriaxone sodium impurity 09
Cefradine Impurity 8 Cefradine Impurity 8 30959-67-2 C16H19N3O4S
Dobutamine Impurity 3 Dobutamine Impurity 3 334947-75-0 C19H25NO3
Anastrozole Impurity 19 Anastrozole Impurity 19 1301724-97-9 C19H21N3O2
Biotin Impurity Biotin Impurity 171232-73-8 C19H18N2O2S
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