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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
(6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione (6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione 531500-48-8 C22H17N3O5
1-(3,5-Dihydroxyphenyl)-2-[(1,1-diMethylethyl)(phenylMethyl)aMino]ethanone HydrobroMide 1-(3,5-Dihydroxyphenyl)-2-[(1,1-diMethylethyl)(phenylMethyl)aMino]ethanone HydrobroMide 94109-61-2 C19H23NO3
2-Methyl-5-(3-(4-(Methylsulfonyl)phenyl)furan-2-yl)pyridine 2-Methyl-5-(3-(4-(Methylsulfonyl)phenyl)furan-2-yl)pyridine 307531-96-0 C17H15NO3S
3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzenesulfonic Acid 3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzenesulfonic Acid 437717-43-6 C17H20N4O5S
3-[5-(1,5-Dioxo-5-(p-fluophenylpentyl]-4R-phenyl-2-oxazolidinone 3-[5-(1,5-Dioxo-5-(p-fluophenylpentyl]-4R-phenyl-2-oxazolidinone 404874-93-7 C20H18FNO4
5-[Bis(2-chloroethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid Methyl Ester 5-[Bis(2-chloroethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid Methyl Ester 109882-25-9 C17H23Cl2N3O2
Butanoic acid, 4-chloro-3-hydroxy-, (3S)- Butanoic acid, 4-chloro-3-hydroxy-, (3S)- 106941-19-9 C4H7ClO3
2- hydroxyl olopatadine hydrochloride iMpurity 2- hydroxyl olopatadine hydrochloride iMpurity 1331822-32-2 C21H23NO4
Anastrozole iMpurity D Anastrozole iMpurity D
Anastrozole iMpurity D Anastrozole iMpurity D
EMtricitabine iMpurity D EMtricitabine iMpurity D
IMp. D (EP) as SodiuM Salt IMp. D (EP) as SodiuM Salt
RocuroniuMbroMide iMpurity G RocuroniuMbroMide iMpurity G
5,11-bisthio-(R,R)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,8-diketone 5,11-bisthio-(R,R)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,8-diketone 72744-67-3 C8H10N2O2S2
ethyl 2-(3-hydroxyphenyl)-4-methylthiazole-5-Carboxylate ethyl 2-(3-hydroxyphenyl)-4-methylthiazole-5-Carboxylate 209538-87-4 C13H13NO3S
Pyridine, 3-Methoxy-2-Methyl-4-nitro-, 1-oxide Pyridine, 3-Methoxy-2-Methyl-4-nitro-, 1-oxide 15931-25-6 C7H8N2O4
1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 161771-76-2 C9H10N2O3S
(Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate (Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate 881995-70-6 C11H10F3NO2
(1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester 171596-44-4 C20H18N2O4
Amlodipine-d4 Amlodipine-d4 1185246-14-3 C20H25ClN2O5
rac Des(isopropylaMino) Acebutolol Diol rac Des(isopropylaMino) Acebutolol Diol 96480-91-0 C15H21NO5
(17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile (17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile 106111-42-6 C20H25NO2
(3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine (3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine 177793-80-5 C18H26N2
4-(4-Fluorophenyl)-1-Methyl- 4-(4-Fluorophenyl)-1-Methyl- 1012886-75-7 C12H15ClFN
5'(S)-Hydroxy SiMvastatin  DISCONTINUED 5'(S)-Hydroxy SiMvastatin DISCONTINUED 149949-05-3 C25H38O6
5'-Epi-LaMivudine 5'-Epi-LaMivudine 136846-20-3 C8H11N3O3S
N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) 686299-20-7 C8H14N4O6
SiMvastatin 4'-Methyl Ether SiMvastatin 4'-Methyl Ether 864357-88-0 C26H40O5
(2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane (2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane 162849-95-8 C28H35N3O5S
1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 885340-11-4 C32H34F3N3O4
4-DesMethoxy-4-broMo TriMethopriM 4-DesMethoxy-4-broMo TriMethopriM 16285-82-8 C13H15BrN4O2
Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate 82398-34-3 C12H24N5O5Pt2+
3-(1-Naphthalenyloxy)propiophenone 3-(1-Naphthalenyloxy)propiophenone 41198-42-9 C19H16O2
2-(1,3,2-Dioxaborinan-2-yl)benzamide 2-(1,3,2-Dioxaborinan-2-yl)benzamide 2377611-18-0 C10H12BNO3
Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) 5740-62-5 C24H32O6
6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 926319-53-1 C17H14BrNO4
(2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid (2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid C26H31N2O5
2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid
(Diketopiperazine) 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine) C29H42N8O18S4
Methoxyvinpocetine Methoxyvinpocetine
(1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate (1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate 229614-51-1 C16H30N4O4
Bis(4-fluorobenzyl)aMine, 97% Bis(4-fluorobenzyl)aMine, 97% 134227-41-1 C14H13F2N
(3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester (3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester 1292296-09-3 C38H52N6O7
L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride 142963-69-7 C14H23ClN6O4
8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 432543-89-0 C19H20Cl2N2
1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 141745-71-3 C25H29N3O2
PF 2825 PF 2825 153012-65-8 C21H28N2O5S
3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 444057-64-1 C24H27ClN4O6S2
Ertapenem Dimer Form D Impurity Ertapenem Dimer Form D Impurity 1199797-41-5 C44H50N6O14S2
S 00218 S 00218 92700-82-8 C15H22N2O4
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
Loratadine IMpurity D Loratadine IMpurity D C22H23ClN2O2
PeMetrexed EP IMpurity A PeMetrexed EP IMpurity A 869791-42-4 C21H23N5O6
Itraconazole EP IMpurity G Itraconazole EP IMpurity G
2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 62369-72-6 C36H58O10
10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 146-21-4 C17H20N2OS
(1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride (1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride 1402222-66-5 C9H10ClF2N
IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine 216581-01-0 C30H30N2
21-Dehydro-6α-Methyl Prednisolone 21-Dehydro-6α-Methyl Prednisolone 58636-50-3 C22H28O5
α-Hydroxy Flurbiprofen α-Hydroxy Flurbiprofen 61466-95-3 C15H13FO3
5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 1391194-45-8 C20H21NO3S
9-AcridinaMine, 6-chloro-2-ethoxy- 9-AcridinaMine, 6-chloro-2-ethoxy- 855939-48-9 C15H13ClN2O
1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 221615-72-1 C15H15NOS
Edaravone Edaravone 68195-63-1 C30H26N6O3
Caspofungin IMpurity A Caspofungin IMpurity A 1202167-57-4 C51H86N10O15
DesdifluoroMethoxy Hydroxy Pantoprazole DesdifluoroMethoxy Hydroxy Pantoprazole 1261238-06-5 C15H15N3O4S
Levofloxacin Hydroxy Acid Levofloxacin Hydroxy Acid 1036016-10-0 C18H21F2N3O4
N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine 91147-43-2 C11H11N5
Nor Lidocaine Hydrochloride Nor Lidocaine Hydrochloride 7729-94-4 C12H19ClN2O
rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate 136310-66-2 C18H19NO3S2
(11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one (11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one 709615-25-8 C30H37NO4
4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 1187954-57-9 C32H37NO3
(2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride (2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride 1370331-33-1 C8H17NO5
(3S,5R)-Rosuvastatin (3S,5R)-Rosuvastatin 1242184-42-4 C22H28FN3O6S
(S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide (S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide 119714-13-5 C10H16N2O3S
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Avanafil IMpurity 6 Avanafil IMpurity 6
Cefoxitin iMpurity F (S-Methoxy cefoxitin) Cefoxitin iMpurity F (S-Methoxy cefoxitin)
Clopidogrel IMpurity 1 Clopidogrel IMpurity 1 C15H14ClNO2S
LincoMycin iMpurity A LincoMycin iMpurity A
Posaconazole iMpurity 1 Posaconazole iMpurity 1
Riociguat IMpurtiy Riociguat IMpurtiy 2920299-23-4
TelMisartan IMpurity E TelMisartan IMpurity E
IverMectin B1 Mono-sugar Derivative IverMectin B1 Mono-sugar Derivative 71837-27-9 C41H62O11
Desethyl Acetate (E)-CefuroxiMe Axetil Desethyl Acetate (E)-CefuroxiMe Axetil 97232-97-8 C16H16N4O8S
6-AMino-5-azacytidine 6-AMino-5-azacytidine 105331-00-8 C8H13N5O5
N-Methyl-3-phenylpropan-1-aMine hydrochloride
(RelCpd B) N-Methyl-3-phenylpropan-1-aMine hydrochloride (RelCpd B) 30684-07-2 C10H16ClN
1-[2-[(2,6-diMethylphenyl)thio]phenyl]- Piperazine 1-[2-[(2,6-diMethylphenyl)thio]phenyl]- Piperazine 508233-76-9 C18H22N2S
1-NaphthaleneMethanaMine, α-Methyl-N-[[3-(trifluoroMethyl)phenyl]Methyl]-, (αR)- 1-NaphthaleneMethanaMine, α-Methyl-N-[[3-(trifluoroMethyl)phenyl]Methyl]-, (αR)- 1229512-52-0 C20H18F3N
Benzoic acid, 2-[[[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]aMino]carbonyl]- Benzoic acid, 2-[[[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]aMino]carbonyl]- 1365267-37-3 C22H21N3O7
NSC 609249 NSC 609249 51012-67-0 C12H20ClNO2
Doxorubicin Impurity 6 Doxorubicin Impurity 6 69429-21-6 C26H27NO11
Etoricoxib Impurity 11 Etoricoxib Impurity 11 202409-31-2 C17H13ClN2O2S
Levofloxacin Tetrafluoro Impurity 1 Levofloxacin Tetrafluoro Impurity 1 110548-02-2 C15H15F4NO4
Penicillin F Potassium Salt Penicillin F Potassium Salt 97299-13-3 C14H21KN2O4S
Olaparib Impurity 31 Olaparib Impurity 31 458535-34-7 C12H18N2O2
Macitentan impurity A Macitentan impurity A 441798-25-0 C17H16Br2N6O4S
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