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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
Cefdinir Impurity S(CP) Cefdinir Impurity S(CP)
Cefodizime oxidation Impurity 1 Cefodizime oxidation Impurity 1 111874-11-4 C20H20N6O7S4
Spectinomycin Impurity F Spectinomycin Impurity F
(7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium (7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium C29H38N5O10+
3-pentylisobenzofuran-1(3H)-one 3-pentylisobenzofuran-1(3H)-one 111943-62-5 C13H16O2
2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2036283-13-1 C10H10N4O3S2
Levofloxacin Impurity 18 Levofloxacin Impurity 18 138998-47-7 C14H13F4NO3
N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1) N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1)
N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide C18H17N5O
methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate 1616761-01-3 C17H23N5O3
Labetalol iMpurity Labetalol iMpurity 2731858-23-2
ZXANKCFSGFEBQW-PFEQFJNWSA-N ZXANKCFSGFEBQW-PFEQFJNWSA-N 1258938-54-3
TWEORVZIMOFLDE-MXTNKPTQSA-N TWEORVZIMOFLDE-MXTNKPTQSA-N 1706671-50-2 C25H31N5O9S
WGEFOIHAXGTXJE-RTMVWDMESA-N WGEFOIHAXGTXJE-RTMVWDMESA-N 1373171-12-0 C48H61NO14
ZIMIAPVHHUISPY-CLFYSBASSA-N ZIMIAPVHHUISPY-CLFYSBASSA-N 866954-86-1 C15H15F3O5
2-Propanone, 1,3-bis(4-methoxyphenyl)- 2-Propanone, 1,3-bis(4-methoxyphenyl)- 29903-09-1 C17H18O3
1,3-bis(2-chloroethyl)benzimidazolin-2-one 1,3-bis(2-chloroethyl)benzimidazolin-2-one 55470-74-1 C11H12Cl2N2O
Nintedanib Impurity A (Intedanib Impurity A ) Nintedanib Impurity A (Intedanib Impurity A )
1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine 1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine 332374-42-2 C14H20N2O4S
ApovincaMinic Acid Ethyl Ester N-Oxide ApovincaMinic Acid Ethyl Ester N-Oxide 109741-24-4 C22H26N2O3
Afatinib Impurity M Afatinib Impurity M
Ornidazole  Impurity Ornidazole Impurity 1100750-18-2
4-(3-nitrophenyl)-3-Morpholinone 4-(3-nitrophenyl)-3-Morpholinone 845729-43-3 C10H10N2O4
PDXA-226 PDXA-226 352637-51-5 C14H14N2O
Ropivacaine-ET-R Ropivacaine-ET-R 98626-60-9 C16H24N2O
Ropivacaine-iPr-S Ropivacaine-iPr-S 265120-58-9 C17H26N2O
(S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine (S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine 1384080-33-4 C19H21NOS
methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate C17H15NO4S
Apremilast impurity 15 Apremilast impurity 15
Aprepitant Impurity 22 Aprepitant Impurity 22 934540-48-4 C20H16F7NO2
Aprepitant Impurity 9 Aprepitant Impurity 9 219821-37-1 C24H25F7N4O4
Betamethasone EP Impurity I Betamethasone EP Impurity I 185613-69-8 C22H29FO5
Canagliflozin Impurity 14 Canagliflozin Impurity 14 842133-17-9 C24H25FO5S
Carfilzomib Impurity F Carfilzomib Impurity F
Cefamandole Impurity A Cefamandole Impurity A 1947364-12-6 C17H16N2O6S
Dapagliflozin Impurity 19 Dapagliflozin Impurity 19 1469910-84-6 C29H33ClO10
Docetaxel EP Impurity A Docetaxel EP Impurity A
Empagliflozin Impurity 21 Empagliflozin Impurity 21
Febuxostat Impurity 43 Febuxostat Impurity 43
Formoterol Impurity 20 Formoterol Impurity 20
Hydroxychloroquine Impurity 2 Hydroxychloroquine Impurity 2
Ibrutinib Impurity 14 Ibrutinib Impurity 14 2417548-76-4 C50H48N12O4
Imatinib impurity 11 Imatinib impurity 11
Isavuconazole Impurity 2 Isavuconazole Impurity 2 2001051-99-4 C13H12F2N4O
Isavuconazole Impurity 25 Isavuconazole Impurity 25
Loxoprofen Impurity 18 Loxoprofen Impurity 18 99807-54-2 C11H13BrO2
Mupirocin EP Impurity D Mupirocin EP Impurity D 71087-97-3 C26H44O9
N-Acetyl-Lys-Octreotide N-Acetyl-Lys-Octreotide 173606-11-6 C51H68N10O11S2
Olaparib Impurity 3 Olaparib Impurity 3
Posaconazole Impurity 33 Posaconazole Impurity 33 182210-71-5 C12H13F2IO2
Posaconazole Impurity 38 Posaconazole Impurity 38
Posaconazole Impurity 62 Posaconazole Impurity 62
Roxithromycin Impurity J Roxithromycin Impurity J
Sitagliptin Impurity 21 Sitagliptin Impurity 21 2088771-60-0 C20H19F6N5O5
1-(4-AMinophenyl)-5,6-dihydro-3-(4-Morpholinyl)-2(1h)-pyridinone 1-(4-AMinophenyl)-5,6-dihydro-3-(4-Morpholinyl)-2(1h)-pyridinone 1267610-26-3 C15H19N3O2
Erlotinib IMpurity C Erlotinib IMpurity C 1312937-41-9 C15H20N2O5
Cinacalcet IMpurity Cinacalcet IMpurity 1229224-93-4 C22H26F3N
SalMeterol iMpurity SalMeterol iMpurity 144391-74-2 C25H37NO4
AzithroMycin iMpurity R AzithroMycin iMpurity R
ceftazidiMe iMpurity E ceftazidiMe iMpurity E
CefuroxiMe Axetil iMpurity C CefuroxiMe Axetil iMpurity C 76598-06-6 C18H15Cl3N4O9S
Rupatadine iMpurity D Rupatadine iMpurity D
2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine 2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine 428854-24-4 C17H15FN8
AR-C 124910XX AR-C 124910XX 220347-05-7 C21H24F2N6O3S
Doxazosin iMpurity Doxazosin iMpurity 1219803-95-8 C23H26ClN5O5
Montelukast iMpurity Montelukast iMpurity
Vildagliptin iMpurity A-F Vildagliptin iMpurity A-F 1846606-32-3 C7H10N2O3
NM-2201 NM-2201 837112-21-7 C24H22FNO2
5a-17-(3-Pyridyl)-16-androstene-3-one 5a-17-(3-Pyridyl)-16-androstene-3-one C24H31NO
AMpicillin EP IMpurity E AMpicillin EP IMpurity E
Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi
Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi
AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2)
 tans, trans IsoMer) AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2) tans, trans IsoMer) 1248429-33-5
Ceftriaxone IMpurit B Ceftriaxone IMpurit B
Flucloxacillin IMpurity F Flucloxacillin IMpurity F
IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate) IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate) 562091-56-9 C20H22N3O4P
Lercanidipine IMpurity B Lercanidipine IMpurity B 1119226-97-9 C35 H37 N3 O6
Milrinone IMpurity 2 Milrinone IMpurity 2 400063-10-7 C12H7N3O2
Moxifloxacin Decarboxy Analog Moxifloxacin Decarboxy Analog 1322062-57-6 C20H24FN3O2
Naratriptan IMpurity E Naratriptan IMpurity E 1346746-73-3 C20H32N4O4S2
PraMipexole DiMer IMpurity II PraMipexole DiMer IMpurity II 2206826-82-4 C20H32N6S2
Rosuvastatin Substituted Hydroxy Pentenoic Acid Rosuvastatin Substituted Hydroxy Pentenoic Acid 910867-11-7 C20H24FN3O5S
EthanediaMide  iMpurity k EthanediaMide iMpurity k 2803419-58-9 C2H4N2O2
(1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 1445580-43-7 C14H21N5O5S
D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)- 160709-02-4 C14H15F2N3O2
Bivalirudin iMpurity Bivalirudin iMpurity 72378-50-8 C6H8N2O4
2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid 2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid 55699-12-2 C14H20O3
(S)-Fesoterodine FuMarate (S)-Fesoterodine FuMarate 1431511-18-0 C30H41NO7
(3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity) (3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity) 106939-30-4 C19H22FN3O4
SofosBuvir Impurity 38 SofosBuvir Impurity 38
SofosBuvir Impurity 61 SofosBuvir Impurity 61
Suvorexant Impurity 2 Suvorexant Impurity 2 1276666-19-3 C23H23ClN6O2
Tenofovir impurity L Tenofovir impurity L
Ticagrelor Impurity 27 Ticagrelor Impurity 27 1402150-01-9 C19H26ClN5O5S
Ticagrelor impurity P Ticagrelor impurity P
Tramadol Impurity 1 Tramadol Impurity 1 66170-32-9 C16H25NO2
Lidocaine EP Impurity G Lidocaine EP Impurity G 42459-30-3 C13H20N2O
methyl 1,4-dihydroxy-7-phenoxyisoquinoline-3-carboxylate methyl 1,4-dihydroxy-7-phenoxyisoquinoline-3-carboxylate 1421312-32-4 C17H13NO5
1-(2,3-DIMETHYLPHENYL)PROPAN-1-OL 1-(2,3-DIMETHYLPHENYL)PROPAN-1-OL 944268-64-8 C11H16O
4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole 4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole 1448355-87-0 C16H12ClNO
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