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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
4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylicacid, 5,6-dihydro-8-hydroxy-5-methyl-6-oxo-, ethyl ester 4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylicacid, 5,6-dihydro-8-hydroxy-5-methyl-6-oxo-, ethyl ester 131666-45-0 C15H15N3O4
α,α-Bis[2-(dimethylamino)ethyl]- α,α-Bis[2-(dimethylamino)ethyl]- 1246816-57-8 C16H24ClN3
(3R,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester (3R,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester 125971-93-9 C11H19NO4
2-Desethoxy-2-hydroxy-2H-2-ethyl Candesartan Cilexetil 2-Desethoxy-2-hydroxy-2H-2-ethyl Candesartan Cilexetil 1185256-03-4 C33H34N6O6
D-(-)-3-Acetylthio-2-methylpropionic acid D-(-)-3-Acetylthio-2-methylpropionic acid 76497-39-7 C6H10O3S
5,4'-DIHYDROXY-7-METHOXYISOFLAVONE-4'-O-GLUCOSIDE 5,4'-DIHYDROXY-7-METHOXYISOFLAVONE-4'-O-GLUCOSIDE 89595-66-4 C22H22O10
OLANEXIDINE OLANEXIDINE 146510-36-3 C17H27Cl2N5
1-(2-ETHOXY-ETHYL)-1,3-DIHYDRO-BENZOIMIDAZOL-2-ONE 1-(2-ETHOXY-ETHYL)-1,3-DIHYDRO-BENZOIMIDAZOL-2-ONE 101953-61-1 C11H14N2O2
3-Cyano-4-(2-methylpropoxy)benzenecarbothioamide 3-Cyano-4-(2-methylpropoxy)benzenecarbothioamide 163597-57-7 C12H14N2OS
1-BOC-4-(2-AMINO-4-PYRIDINYL)-PIPERAZINE 1-BOC-4-(2-AMINO-4-PYRIDINYL)-PIPERAZINE 571189-23-6 C14H22N4O2
1,3,5,7-Tetranitroadamantane 1,3,5,7-Tetranitroadamantane 75476-36-7 C10H12N4O8
Fexofenadinone Fexofenadinone 76811-98-8 C32H37NO4
6-(3-CHLOROPHENYL)-1,3,5-TRIAZINE-2,4-DIAMINE 6-(3-CHLOROPHENYL)-1,3,5-TRIAZINE-2,4-DIAMINE 4514-54-9 C9H8ClN5
α-Methyl-3,4-dihydroxy-L-phenylalanine methyl ester α-Methyl-3,4-dihydroxy-L-phenylalanine methyl ester 18181-08-3 C11H15NO4
(6R,7R)-3-Chloromethyl-7-methoxy-8-oxo-7-(p-toluoylamino)-5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid diphenylmethyl ester (6R,7R)-3-Chloromethyl-7-methoxy-8-oxo-7-(p-toluoylamino)-5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid diphenylmethyl ester 68314-38-5 C30H27ClN2O6
Methyl a-formylphenylacetate Methyl a-formylphenylacetate 5894-79-1 C10H10O3
1-Butanesulfonic acid methyl ester 1-Butanesulfonic acid methyl ester 2374-69-8 C5H12O3S
Free and total Chlorine, ion specific meter Free and total Chlorine, ion specific meter
N-Desethyl-N-propyl Oxybutynin N-Desethyl-N-propyl Oxybutynin 1215677-72-7 C23H33NO3
3-Oxo Atorvastatin 3-Oxo Atorvastatin 887196-30-7 C33H33FN2O5
Octyl Orlistat Octyl Orlistat 1243011-56-4 C31H57NO5
1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methyl-isoquinoline 1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methyl-isoquinoline 23824-25-1 C10H13NO2
(E)-Cefetamet Pivoxil (E)-Cefetamet Pivoxil 1705612-82-3 C20H25N5O7S2
{3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol {3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol 1018676-02-2 C18H27N3O3S
{3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol {3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol 1018676-02-2 C18H27N3O3S
8-Dechloro-9-chloro Desloratadine 8-Dechloro-9-chloro Desloratadine 117811-13-9 C19H19ClN2
Acyclovir L-Isoleucinate Acyclovir L-Isoleucinate 142963-63-1 C14H22N6O4
Aripiprazole N4-Oxide Aripiprazole N4-Oxide 573691-11-9 C23H27Cl2N3O3
Carvedilol Bisalkylpyrocatechol IMpurity Carvedilol Bisalkylpyrocatechol IMpurity 1346602-98-9 C40H42N4O6
Decarboxyl Ofloxacin Decarboxyl Ofloxacin 123155-82-8 C17H20FN3O2
o-AdaMantylanisole o-AdaMantylanisole 43109-77-9 C17H22O
Hydroxyzine Acetic Acid Dihydrochloride Hydroxyzine Acetic Acid Dihydrochloride 83881-56-5 C23H29ClN2O4
(S)-Duloxetine SuccinaMide (S)-Duloxetine SuccinaMide 199191-66-7 C22H23NO4S
4-Acetyl Rhein 4-Acetyl Rhein 875535-36-7 C17H10O7
1-(2,6-dichlorophenyl)piperazine 1-(2,6-dichlorophenyl)piperazine 63386-61-8 C10H12Cl2N2
1-(2,6-dichlorophenyl)piperazine 1-(2,6-dichlorophenyl)piperazine 63386-61-8 C10H12Cl2N2
Ropivacaine N-Oxide Ropivacaine N-Oxide 1391053-59-0 C17H26N2O2
Methyl 2-CarbaMoylbenzoate Methyl 2-CarbaMoylbenzoate 90564-02-6 C9H9NO3
3-vinylphenyl ethyl(Methyl)-carbaMate 3-vinylphenyl ethyl(Methyl)-carbaMate 1346602-84-3 C12H15NO2
AMisulpride IMpurity D AMisulpride IMpurity D 71676-00-1 C16H25N3O4S
1,2-Benzenedicarboxylic acid, 3-aMino-, 1,2-diethyl ester 1,2-Benzenedicarboxylic acid, 3-aMino-, 1,2-diethyl ester 62351-80-8 C12H15NO4
AFuroseMide IMp. A (EP) AFuroseMide IMp. A (EP)
(1R)-3,4-Dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic acid ethyl ester (1R)-3,4-Dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic acid ethyl ester 180468-41-1 C18H19NO2
2-[4-[(RS)-(4-Chlorophenyl)phenylMethyl]-piperazin-1-yl]ethanolDihydrochloride 2-[4-[(RS)-(4-Chlorophenyl)phenylMethyl]-piperazin-1-yl]ethanolDihydrochloride C19H25Cl3N2O
CAPECITABINE related substance USP CAPECITABINE related substance USP 1262133-68-5 C20H30FN3O9
4-AMino-N-[(1-ethyl-2-pyrrolidinyl)Methyl]-5-(ethylsulfonyl)- 2-MethoxybenzaMide N-Oxide 4-AMino-N-[(1-ethyl-2-pyrrolidinyl)Methyl]-5-(ethylsulfonyl)- 2-MethoxybenzaMide N-Oxide 71676-01-2 C17H27N3O5S
3-[(4-AMino-2-Methyl-5-pyriMidinyl)Methyl]-4-Methyl-5-[2-(sulfooxy)ethyl]thiazoliuM  Inner Salt 3-[(4-AMino-2-Methyl-5-pyriMidinyl)Methyl]-4-Methyl-5-[2-(sulfooxy)ethyl]thiazoliuM Inner Salt 2380-61-2 C12H16N4O4S2
1,4-Bis-[4-[4-Methyl-3-[[4-(pyridin-3-yl)pyriMidin-2-yl]aMino]phenyl]carbaMoyl]benzylpiperazine 1,4-Bis-[4-[4-Methyl-3-[[4-(pyridin-3-yl)pyriMidin-2-yl]aMino]phenyl]carbaMoyl]benzylpiperazine 1365802-18-1 C52H48N12O2
[6R-[6α,7β(R*)]]-7-[(AMinophenylacetyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0 [6R-[6α,7β(R*)]]-7-[(AMinophenylacetyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0 79750-46-2 C16H17N3O4S
SalMeterol EP IMpurity D SalMeterol EP IMpurity D 1391052-04-2 C34H47NO7
3-Pyridinecarboxylic Acid 2-AMinoethyl Ester Dihydrochloride 3-Pyridinecarboxylic Acid 2-AMinoethyl Ester Dihydrochloride 87330-70-9 C8H11ClN2O2
1β-Hydroxy-6α-Methyl-1,4-androstadiene-3,17-dione 1β-Hydroxy-6α-Methyl-1,4-androstadiene-3,17-dione 61919-52-6 C20H26O3
5-Fluoro ent-LaMivudine Acid D-Menthol Ester 5-Fluoro ent-LaMivudine Acid D-Menthol Ester 764659-79-2 C18H26FN3O4S
Tricyclo[3.3.1.13,7]decan-1-aMine, 3,5,7-triMethyl-, hydrochloride Tricyclo[3.3.1.13,7]decan-1-aMine, 3,5,7-triMethyl-, hydrochloride 15210-60-3 C13H24ClN
4'-Hydroxy TorseMide 4'-Hydroxy TorseMide 99300-67-1 C16H20N4O4S
7,10-Dimethoxy-10-DAB III 7,10-Dimethoxy-10-DAB III 183133-94-0 C31H40O10
IMp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol IMp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol
PeMetrexed EP IMpurity D PeMetrexed EP IMpurity D 144051-68-3 C25H28N6O9
SuMatriptan EP IMpurity F SuMatriptan EP IMpurity F 2074615-63-5 C13H17N3O2S
2-[[(5-hydroxy-1H-benziMidazol-2-yl)sulfinyl]Methyl]-3,5-diMethyl-1-4(1H)-pyridone 2-[[(5-hydroxy-1H-benziMidazol-2-yl)sulfinyl]Methyl]-3,5-diMethyl-1-4(1H)-pyridone C15H15N3O3S
Perindopril Impurity Perindopril Impurity
4-Acetoxyisophthalic Acid 4-Acetoxyisophthalic Acid 5985-26-2 C10H8O6
Ganciclovir Dipropionate Ganciclovir Dipropionate 86357-20-2 C15H21N5O6
IMp. A (EP): (RS)-2-Chloro-N-(2-Methylphenyl)-PropanaMide IMp. A (EP): (RS)-2-Chloro-N-(2-Methylphenyl)-PropanaMide 39084-88-3 C10H11Cl2NO
3-((butyryloxy)Methyl) 5-Methyl 4-(2',3'-dichlorophenyl)-2,6-diMethylpyridine-3,5-dicarboxylate 3-((butyryloxy)Methyl) 5-Methyl 4-(2',3'-dichlorophenyl)-2,6-diMethylpyridine-3,5-dicarboxylate 188649-48-1 C21H21Cl2NO6
Bis Valacyclovir (~90%) Bis Valacyclovir (~90%) 1356019-51-6 C27H40N12O8
Flupirtine DiMer Flupirtine DiMer 1417916-52-9 C30H32F2N8O4
(S)-2-((R)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-4-benzylMorpholin-3-one (S)-2-((R)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-4-benzylMorpholin-3-one 327623-36-9 C21H19F6NO3
3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide 3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide 2304623-36-5 C16H14N2O3S
(S)-2-(3,4-Difluorophenyl)oxirane (S)-2-(3,4-Difluorophenyl)oxirane 1006376-63-1 C8H6F2O
EsoMeprazole iMpurity EsoMeprazole iMpurity 1424857-86-2 C11H15NO3
AMoxicillin iMpurity L AMoxicillin iMpurity L C16H19N3O5S
AMoxicillin iMpurity L AMoxicillin iMpurity L C16H19N3O5S
Azilsartan iMpurity G Azilsartan iMpurity G
(R)-N-(1-(naphthalen-1-yl)ethyl)-3-(M-tolyl)propan-1-aMine (R)-N-(1-(naphthalen-1-yl)ethyl)-3-(M-tolyl)propan-1-aMine 253337-60-9 C22H25N
3-((3R,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanaMide 3-((3R,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanaMide 1675248-19-7 C16H22N6O2
Blonanserin iMpurity Blonanserin iMpurity 132810-83-4 C23H30FN3
Deferasirox iMpurity Deferasirox iMpurity 1688656-83-8 C42H28N6O8S
Lercanidipine iMpurity Lercanidipine iMpurity 320750-19-4 C37H43N3O6
AMpicillin EP IMpurity J AMpicillin EP IMpurity J 6489-58-3 C13H20N2O4S
Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide) Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide) 120512-04-1 C17H23N5O2
Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide) Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide) 120512-04-1 C17H23N5O2
CefathiaMidine Lactone CefathiaMidine Lactone 905712-22-3 C17H24N4O4S2
Cinacalcet IMpurity 9 Cinacalcet IMpurity 9 802918-36-1 C22H24F3N
Doxorubicin IMpurity B Doxorubicin IMpurity B 106401-68-7 C29H34BrNO11
EzetiMibe IMpurity B EzetiMibe IMpurity B
Fluconazole IMpurity [1, 3-Bis(1H-1, 2, 4-Triazole-1-yl)propan-2-one] Fluconazole IMpurity [1, 3-Bis(1H-1, 2, 4-Triazole-1-yl)propan-2-one] 1449785-88-9 C10H7F2N3O
HydroxyMethylidene thione HydroxyMethylidene thione 1320360-86-8 C15H18N4OS
Lansoprazole IMpurity I Lansoprazole IMpurity I
Lapatinib IMpurity 10 Lapatinib IMpurity 10 1152131-73-1 C26H17ClFN3O4
Metronidazole IMpurity D Metronidazole IMpurity D
PraMipexole IMpurity V (PraMipexole IMpurity Z) PraMipexole IMpurity V (PraMipexole IMpurity Z)
Prasugrel Acetyl IMpurity Prasugrel Acetyl IMpurity 1443034-67-0 C18H18FNO3S
Propofol IMpurity G Propofol IMpurity G
SalMeterol IMpurity A SalMeterol IMpurity A C25H37NO4
Sitagliptin Defuoro IMpurity 3 Sitagliptin Defuoro IMpurity 3 851307-12-5 C15H19F2NO4
Sitagliptin N-Boc IMpurity Sitagliptin N-Boc IMpurity 486460-23-5 C21H23F6N5O3
SulbactaM IMpurity D SulbactaM IMpurity D
Valsartan N2-Trityl IMpurity Valsartan N2-Trityl IMpurity
Vardenafil IMpurity 3 Vardenafil IMpurity 3 1255919-01-7 C26H30N6O4S
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