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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
Ampicillin EP Impurity M Ampicillin EP Impurity M 114977-84-3 C48H57N9O12S3
Aprepitant Impurity 12 Aprepitant Impurity 12 172673-23-3 C23H21F7N4O4
Aprepitant Impurity 18 Aprepitant Impurity 18
Blonanserin impurity D Blonanserin impurity D
Captopril impurity 3 Captopril impurity 3
Empagliflozin Impurity 18 Empagliflozin Impurity 18
Empagliflozin Impurity 24 Empagliflozin Impurity 24
FeBuxostat impurity 31 FeBuxostat impurity 31
Formoterol Fumarate Dihydrate EP Impurity I Formoterol Fumarate Dihydrate EP Impurity I 532414-36-1 C19H24N2O4
Fosaprepitant Impurity 3 Fosaprepitant Impurity 3
Fosfomycin Trometamol EP Impurity D Fosfomycin Trometamol EP Impurity D 1262243-12-8 C10H25NO11P2
Isavuconazole Impurity 17 Isavuconazole Impurity 17
Isavuconazole Impurity 5 Isavuconazole Impurity 5
Moxifloxacin Impurity 21 Moxifloxacin Impurity 21
Mupirocin EP Impurity A Mupirocin EP Impurity A C26H44O9
Nifendipine Impurity G Nifendipine Impurity G 74378-10-2 C15H14N2O6
Olaparib Impurity 5 Olaparib Impurity 5
Plerixafor Impurity 5 Plerixafor Impurity 5
Methyl (1-benzyl-4-Methylpiperidin-3-yl)carbaMate Methyl (1-benzyl-4-Methylpiperidin-3-yl)carbaMate 1206875-41-3 C15H22N2O2
S-(-)-[1-(3-Methoxyphenyl)ethyl]-N,N-diMethylaMine S-(-)-[1-(3-Methoxyphenyl)ethyl]-N,N-diMethylaMine 889443-69-0 C11H17NO
N-(4-aMinophenyl)-2-chloro-N-MethylacetaMide N-(4-aMinophenyl)-2-chloro-N-MethylacetaMide 855860-75-2 C9H11ClN2O
Posaconazole Impurity 30 Posaconazole Impurity 30
Posaconazole Impurity 35 Posaconazole Impurity 35 1370190-85-4 C14H13F2N3O
Posaconazole Impurity 51 Posaconazole Impurity 51 357189-94-7 C37H40F2N8O5
Posaconazole Impurity 59 Posaconazole Impurity 59
Ramosetron Impurity 13 Ramosetron Impurity 13 183613-77-6 C17H13N3O
Sitafloxacin Impurity 2 Sitafloxacin Impurity 2 C23H10Cl2F4N2O6
Sitagliptin Impurity 10 Sitagliptin Impurity 10 1253056-01-7 C16H14F6N4O2
SofosBuvir Impurity 18 SofosBuvir Impurity 18
sofosBuvir Impurity 35 sofosBuvir Impurity 35
SofosBuvir Impurity 51 SofosBuvir Impurity 51
SofosBuvir Impurity 58 SofosBuvir Impurity 58
Sulbactam EP Impurity G Sulbactam EP Impurity G
Ticagrelor impurity 21 Ticagrelor impurity 21
Tirofiban Impurity 13 Tirofiban Impurity 13 C27H45N3O3
Tocopherol Impurity 1 Tocopherol Impurity 1 3808-26-2 C29H48O2
Tofacitinib impurity U Tofacitinib impurity U
Vortioxetine impurity S Vortioxetine impurity S 1815608-51-5 C18H22N2S
Baloxavir marboxil Baloxavir marboxil 1985606-14-1 C27H23F2N3O7S
Linagliptin N-Acetyl Impurity Linagliptin N-Acetyl Impurity 1803079-49-3 C27H30N8O3
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic acid (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic acid 474668-76-3 C19H16N2O4
Lidocaine  Impurity Lidocaine Impurity 70336-49-1 C20H22N2O2
(E)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide (E)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide 214782-56-6 C12H9F3N2O2
Amoxicillin Impurity  O Amoxicillin Impurity O C16H19N3O5S
Ampicillin Impurity R Ampicillin Impurity R
Spectinomycin Impurity C Spectinomycin Impurity C
Amifostine Impurity 2 Amifostine Impurity 2
Brexpiprazole Impurity Brexpiprazole Impurity 2138169-93-2 C41H47N5O2S2
Cefoxitin impurity EF Cefoxitin impurity EF
Tenofovir Impurity 38 Tenofovir Impurity 38 161760-09-4 C8H11O6PS
N-(4-methyl-3-(3-(4-((4-methylpiperazin-1-yl)methyl)benzoyl)guanidino)phenyl)-4-(4-methylpiperazin-1-yl)benzamide N-(4-methyl-3-(3-(4-((4-methylpiperazin-1-yl)methyl)benzoyl)guanidino)phenyl)-4-(4-methylpiperazin-1-yl)benzamide C33H42N8O2
Apremilast Apremilast 1384440-16-7 C19H20N2O6S
XMUJPIDSOJTMMS-VTBMCCKRSA-N XMUJPIDSOJTMMS-VTBMCCKRSA-N 212505-49-2 C21H30O3
XLMHAABXFLIUNQ-UHFFFAOYSA-N XLMHAABXFLIUNQ-UHFFFAOYSA-N 368451-15-4 C24H26O3
Ibrutinib iMpurity Ibrutinib iMpurity 936351-48-3 C12H13ClN2O
1-Phenyl-5-(pyridin-2-yl)-1,2-dihydropyridin-2-one 1-Phenyl-5-(pyridin-2-yl)-1,2-dihydropyridin-2-one 381725-50-4 C16H12N2O
Abacavir Impurity E Abacavir Impurity E 208762-35-0 C14H20N6O
(1R,5S,6R)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester (1R,5S,6R)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester 347378-74-9 C14H22O4
(3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid CalciuM Salt (3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid CalciuM Salt 254452-96-5 C25H24FNO4
(αZ)-α-(MethoxyiMino)-N-[(5aR,6R)-1,4,5a,6-tetrahydro-1,7-dioxo-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl]-2-furanacetaMide (αZ)-α-(MethoxyiMino)-N-[(5aR,6R)-1,4,5a,6-tetrahydro-1,7-dioxo-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl]-2-furanacetaMide 947723-87-7 C15H13N3O6S
1-[[2-[(2-AMinophenyl)aMino]-5-Methyl-3-thienyl]carbonyl]-4-Methyl-piperazine 1-[[2-[(2-AMinophenyl)aMino]-5-Methyl-3-thienyl]carbonyl]-4-Methyl-piperazine 138564-61-1 C17H22N4OS
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester 452092-31-8 C15H13F2NO4
2-(IsopropylaMino)-2',6'-acetoxylidide Hydrochloride 2-(IsopropylaMino)-2',6'-acetoxylidide Hydrochloride 35891-87-3 C13H21ClN2O
2,2'-IMinobis(N-(2,6-DiMethylphenyl)acetiaMide Hydrochloride 2,2'-IMinobis(N-(2,6-DiMethylphenyl)acetiaMide Hydrochloride 1135231-62-7 C20H26ClN3O2
3,4-O-(DiethylMethylidene) ShikiMic Acid Ethyl Ester 3,4-O-(DiethylMethylidene) ShikiMic Acid Ethyl Ester 943515-58-0 C14H22O5
4-Hydroxy-α1-[[[6-(2-phenylethoxy)hexyl]aMino]Methyl]-1,3-benzenediMethanol 4-Hydroxy-α1-[[[6-(2-phenylethoxy)hexyl]aMino]Methyl]-1,3-benzenediMethanol 94749-02-7 C23H33NO4
5-[2-Ethoxy-5-[(4-Methyl-1-piperazinyl)thioxoMethyl]phenyl]-1,6-dihydro-1-Methyl-3-propyl-7H-pyrazolo[4,3-d]pyriMidine-7-thione 5-[2-Ethoxy-5-[(4-Methyl-1-piperazinyl)thioxoMethyl]phenyl]-1,6-dihydro-1-Methyl-3-propyl-7H-pyrazolo[4,3-d]pyriMidine-7-thione 1333233-46-7 C23H30N6OS2
BIRG 613 BS BIRG 613 BS 287980-85-2 C15H16N4O
Deferasirox Salicyloyl Ester Deferasirox Salicyloyl Ester 1395346-28-7 C28H19N3O6
N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol 1198090-73-1 C36H43N3O7
N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide 253168-86-4 C22H24N2O7S
Ticagrelor IMpurity B Ticagrelor IMpurity B
AtracuriuM IMpurity V AtracuriuM IMpurity V 1075726-86-1 C25H34INO6
Avanafil iMpurity 3 Avanafil iMpurity 3
CitalopraM carboxylic acid iMpurity CitalopraM carboxylic acid iMpurity 440121-09-5 C20H22FNO3
Decitabine iMpurity 6 Decitabine iMpurity 6 178671-74-4 C7H14N4O4
DiazepaM IMpurity E DiazepaM IMpurity E 20927-53-1 C15H11ClN2O
ErtapeneM Side Chain EnantioMer 2 HCl ErtapeneM Side Chain EnantioMer 2 HCl 503607-49-6 C12H15ClN2O3S
MetaMizole IMpurity C (4-MethylaMinoantipyrine) HCl MetaMizole IMpurity C (4-MethylaMinoantipyrine) HCl 856307-27-2 C12H16ClN3O
Ribavirin IMpurity G Ribavirin IMpurity G
Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone 1157938-97-0 C10H7F2N3O
3-Fluoro-4-phenylphenol 3-Fluoro-4-phenylphenol 477860-13-2 C12H9FO
Heptyl Deoctyl FingoliMod Hydrochloride Heptyl Deoctyl FingoliMod Hydrochloride 162361-44-6 C18H32ClNO2
4-Methoxy-3,5-diMethylpyridine 1-Oxide 4-Methoxy-3,5-diMethylpyridine 1-Oxide 91219-89-5 C8H11NO2
N-Ethyl-3-buteno-o-toluidide N-Ethyl-3-buteno-o-toluidide 13936-71-5 C13H17NO
Pramipexole Impurity 21 Pramipexole Impurity 21 104617-86-9 C10H17N3S
Tigecycline Pentacyclic Analog Tigecycline Pentacyclic Analog 1268494-40-1 C27H32N4O9
Tigecycline (open C-ring D-ring) Quinone Tigecycline (open C-ring D-ring) Quinone 1268494-46-7 C26H32N4O8
5-Chloro AcesulfaMe 5-Chloro AcesulfaMe 72827-08-8 C4H4ClNO4S
Pazopanib iMpurity Pazopanib iMpurity
Acetic acid, 2-[2-[2-[4-[(4- chlorophenyl)phenylMethyl]-1-piperazinyl]ethoxy]ethoxy]- Acetic acid, 2-[2-[2-[4-[(4- chlorophenyl)phenylMethyl]-1-piperazinyl]ethoxy]ethoxy]- 682323-77-9 C23H29ClN2O4
edaravone iMpurity edaravone iMpurity 1942007-91-1 C13H14N2O3S
(2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol C24H25FO5S
Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- 219843-76-2 C26H35NO2
5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
Ganciclovir EP Impurity H Ganciclovir EP Impurity H 84222-50-4 C9H13N5O4
2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 97151-10-5 C24H25NO
[S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] [S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] 65134-74-9 C8H14O4S2
(E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone (E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone 935272-10-9 C18H20N4OS
2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 40412-09-7 C13H14O3S2
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