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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
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
2-(7-Methoxynaphthalen-1-yl)acetamide 2-(7-Methoxynaphthalen-1-yl)acetamide 138113-07-2 C13H13NO2
2-(7-Methoxynaphthalen-1-yl)acetamide 2-(7-Methoxynaphthalen-1-yl)acetamide 138113-07-2 C13H13NO2
2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-,1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium benzenesulfonate 2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-,1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium benzenesulfonate 1075727-06-8 C30H37NO9S
1,2,4-Triazolo[4,3-a]pyrazine, 7-[3-amino-1-oxo-4-(2,4,5-trifluorophenyl)-2-butenyl]-5,6,7,8-tetrahydro- 3-(trifluoromethyl)- 1,2,4-Triazolo[4,3-a]pyrazine, 7-[3-amino-1-oxo-4-(2,4,5-trifluorophenyl)-2-butenyl]-5,6,7,8-tetrahydro- 3-(trifluoromethyl)- 847445-81-2 C16H13F6N5O
4-Difluoromethoxy-2-nitro-aniline 4-Difluoromethoxy-2-nitro-aniline 97963-76-3 C7H6F2N2O3
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
5,11-dihydro-6H-11-ethyl-4-Methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one 5,11-dihydro-6H-11-ethyl-4-Methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one 133627-17-5 C14H14N4O
(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
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
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
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
Tigecycline Impurity 6 Tigecycline Impurity 6
Febuxostat Bromo Impurity Febuxostat Bromo Impurity 144060-40-2 C15H16BrNO3S
Meptazinol Impurity Meptazinol Impurity 1314003-47-8 C23H28N2O4
1'H-2,3'-bipyridinyl-2'-one 1'H-2,3'-bipyridinyl-2'-one 101002-01-1 C10H8N2O
Brexpiprazole Impurity D Brexpiprazole Impurity D
Brivaracetam Impurity E Brivaracetam Impurity E
Dapoxetine Impurity 8 Dapoxetine Impurity 8
Irbesartan Impurity 6 Irbesartan Impurity 6 C25H28N6O
Empagliflozin impurity B Empagliflozin impurity B
Varenicline Impurity 1 Varenicline Impurity 1
Voriconazole Impurity 6 Voriconazole Impurity 6
Caspofungin impurity 1 Caspofungin impurity 1
Cabozantinib impurity D Cabozantinib impurity D
Neratinib Impurity 3 Neratinib Impurity 3
Ranitidine Impurity D Ranitidine Impurity D C13H22N4O3S
Metoprolol IMpurity 5 Metoprolol IMpurity 5 C15H25NO3
Mirabegron Impurity 2 Mirabegron Impurity 2
Pemetrexed Impurity 1 Pemetrexed Impurity 1 1644287-26-2 C20H21N5O8
(2R,4S)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoate (2R,4S)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoate 752174-62-2 C20H25NO2
EMpagliflozin  iMpurity 12 EMpagliflozin iMpurity 12
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
Plerixafor Impurity B Plerixafor Impurity B
Tolvaptan impurity3 Tolvaptan impurity3
Vonoprazan Impurity 7 Vonoprazan Impurity 7
Cefazolin impurity F Cefazolin impurity F
Apremilast Impurity 3 Apremilast Impurity 3 88687-92-7 C16H10N2O8
Apixaban Impurity 8 Apixaban Impurity 8 1777781-49-3 C24H23N5O4
Ritodrine BP Impurity D Ritodrine BP Impurity D
Rivaroxaban Impurity 19 Rivaroxaban Impurity 19
Topiroxostat Impurity 4 Topiroxostat Impurity 4 1379342-46-7 C8H8N2O3
Ertapenem impurity 1 Ertapenem impurity 1
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate C26H36NO3
Flomoxef Impurity 3 Flomoxef Impurity 3
Ropivacaine impurity Ropivacaine impurity 1105704-96-8 C12H14N2O3
Agomelatine Impurity 1 Agomelatine Impurity 1 1352139-51-5 C15H19NO2
Diquafosol Impurity 1 Diquafosol Impurity 1 26184-65-6 C18H24N4O17P2
Milnacipran Impurity 3 Milnacipran Impurity 3 1353644-50-4 C15H20ClNO
L-Glutamic acid 1-ethyl ester L-Glutamic acid 1-ethyl ester 52454-78-1 C7H13NO4
Methyl 2-Hydroxy-2-(Thiophen-2-Yl)-2-(Thiophen-3-Yl)Acetate Methyl 2-Hydroxy-2-(Thiophen-2-Yl)-2-(Thiophen-3-Yl)Acetate 28748-67-6 C11H10O3S2
6,7-Dihydro-N-methyl-N-[(3R,4R)-4-methyl-3-piperidinyl]-5H-pyrrolo[2,3-d]pyrimidin-4-amine 6,7-Dihydro-N-methyl-N-[(3R,4R)-4-methyl-3-piperidinyl]-5H-pyrrolo[2,3-d]pyrimidin-4-amine 1812890-23-5 C13H21N5
Sacubitril Impurity 72 Sacubitril Impurity 72 1361408-16-3 C23H27NO4
(1R,2S,3R)-Aprepitant (1R,2S,3R)-Aprepitant 1185502-97-9 C23H21F7N4O3
Clemastine Clemastine 108825-05-4 C21H26ClNO2
4-chloro-7-methoxyquinoline-6-carboxylic acid 4-chloro-7-methoxyquinoline-6-carboxylic acid 771464-30-3 C11H8ClNO3
ethyl (41S,13aR)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate ethyl (41S,13aR)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 85647-43-4 C22H26N2O2
methyl (41R,12R,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12R,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 38990-16-8 C21H26N2O3
Dolutegravir Impurity 3 Dolutegravir Impurity 3 1973402-05-9 C20H19F2N3O5
Cistracurium Besylate EP Impurity D Cistracurium Besylate EP Impurity D 1075726-88-3 C31H39NO9S
(R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-3-chloropropan-1-one (R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-3-chloropropan-1-one 1288338-96-4 C25H25ClN6O2
Bendamustine Impurity 8 Bendamustine Impurity 8 1797881-48-1 C14H19Cl2N3O2
FeBuxostat Impurity 32 FeBuxostat Impurity 32 1805770-41-5 C12H12N2O
Edoxaban Impurity 9(1R,2S,4S) Edoxaban Impurity 9(1R,2S,4S) 2024614-15-9 C21H30ClN5O5
Rivaroxaban Impurity 22 Rivaroxaban Impurity 22 1350288-77-5 C19H18ClN3O5S
Rivaroxaban Impurity 27 Rivaroxaban Impurity 27 1369969-44-7 C21H21N3O5
Abiraterone Impurity 9 Abiraterone Impurity 9 165334-72-5 C24H31NO
Gliclazide Impurity A Gliclazide Impurity A
Medetomidine Impurity 14 Medetomidine Impurity 14 79924-14-4 C13H16N2
Tenofovir Disoproxil Impurity B Tenofovir Disoproxil Impurity B 36817-69-3 C8H11N5O
Ipragliflozin  IMP Ipragliflozin IMP
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