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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
Lincomycin sulfone Impurity 2 Lincomycin sulfone Impurity 2
Palbociclib Impurity 31 Palbociclib Impurity 31 2955712-44-2
Parecoxib Impurity T Parecoxib Impurity T 198471-83-9 C19H18N2O5S
Ropivacaine Impurity 31 Ropivacaine Impurity 31
Ropivacaine Impurity 40 Ropivacaine Impurity 40
Sugammadex sodium Decomposition process Impurity 3 Sugammadex sodium Decomposition process Impurity 3
Sugammadex sodium Org48301 Impurity Sugammadex sodium Org48301 Impurity
Topiroxostat Impurity Ⅱ-3 Topiroxostat Impurity Ⅱ-3
Ivabradine related compound 9 Ivabradine related compound 9 85175-49-1 C12H13NO4
Afatinib impurity 28 Afatinib impurity 28
blonanserin impurity O blonanserin impurity O
Butyphthalide impurity 42 Butyphthalide impurity 42 952412-79-2 C10H12O3
Butyphthalide impurity 48 Butyphthalide impurity 48
Dapoxetine impurity 20 Dapoxetine impurity 20
Empagliflozin Impurity POE Empagliflozin Impurity POE
Febuxostat Impurity 73 Febuxostat Impurity 73
Febuxostat Impurity 78 Febuxostat Impurity 78
Ibrutinib Impurity 21 Ibrutinib Impurity 21 1642571-08-1 C27H30N6O3
4,5,6,7-Tetrahydro-thieno[3,2-c]pyridin-2-ol 2-acetate 4,5,6,7-Tetrahydro-thieno[3,2-c]pyridin-2-ol 2-acetate 1151904-85-6 C9H11NO2S
ethyl (R)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate ethyl (R)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate 110548-06-6 C15H13F2NO4
(1R,3S)-(3-Aminocyclopentyl) methanol (1R,3S)-(3-Aminocyclopentyl) methanol 117957-62-7 C6H13NO
2-[[6-[(3R)-3-tert-butoxycarbonylamino-1-piperidinyl]-3,4-dihydro-2,4-dioxo-3-methyl-1(2H)-pyrimidinyl]methyl]benzonitrile 2-[[6-[(3R)-3-tert-butoxycarbonylamino-1-piperidinyl]-3,4-dihydro-2,4-dioxo-3-methyl-1(2H)-pyrimidinyl]methyl]benzonitrile 1246610-74-1 C23H29N5O4
Canagliflozin Impurity 12 Canagliflozin Impurity 12
Canagliflozin Impurity G Canagliflozin Impurity G
Dolutegravir Impurity 1 Dolutegravir Impurity 1
Empagliflozin impurity F Empagliflozin impurity F
Ibrutinib Impurity 12 Ibrutinib Impurity 12
Nintedanib impurity J Nintedanib impurity J 1139457-10-5 C23H17N3O5
DSKNHVUKATXSCQ-GDVCOKDOSA-N DSKNHVUKATXSCQ-GDVCOKDOSA-N 188915-50-6 C14H14ClN3O4S
Clarthromycin EP Impurity B Clarthromycin EP Impurity B 299409-85-1 C37H67NO13
(4-Chloro-3-trifluoromethyl-phenyl)-carbamic acid tert-butyl ester (4-Chloro-3-trifluoromethyl-phenyl)-carbamic acid tert-butyl ester 352277-93-1 C12H13ClF3NO2
Brexpiprazole Impurity 15 Brexpiprazole Impurity 15
Edoxaban Impurity 16 Edoxaban Impurity 16 480450-69-9 C14H25N5O3
Rivaroxaban Impurity 24 Rivaroxaban Impurity 24
Ticagrelor Ticagrelor 1265919-24-1 C12H21NO5
Clindamycin (2R-cis)-Diastereomer Clindamycin (2R-cis)-Diastereomer 1440605-46-8 C18H33ClN2O5S
Genistein 7,4'-di-O-β-D-glucopyranoside Genistein 7,4'-di-O-β-D-glucopyranoside 36190-98-4 C27H30O15
Aprepitant Impurity 3 Aprepitant Impurity 3
Cabozantinib Impurity F Cabozantinib Impurity F
Cefmetazole sodium Impurity 7 Cefmetazole sodium Impurity 7 60638-57-5 C11H14N6O4S2
Benzene, 1-chloro-2-(dimethoxymethyl)- Benzene, 1-chloro-2-(dimethoxymethyl)- 70380-66-4 C9H11ClO2
(R)-1-chloro-3-{[(4-chlorophenyl)methylene]amino}propan-2-ol (R)-1-chloro-3-{[(4-chlorophenyl)methylene]amino}propan-2-ol 1450915-93-1 C10H11Cl2NO
3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one 3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one 877402-45-4 C6H5F3N4O
4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine 4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine 1026443-48-0 C17H23NO2
epipinoresinol-4'-O-β-D-glucoside epipinoresinol-4'-O-β-D-glucoside 24404-49-7 C26H32O11
Celecoxib Impurity Celecoxib Impurity 170570-09-9 C18H16F3N3O2S
NMEICKDXQPVPKK-UHFFFAOYSA-N NMEICKDXQPVPKK-UHFFFAOYSA-N 120244-82-8 C16H19ClN2O
Lenvatinib Impurity 22 Lenvatinib Impurity 22
Moxifloxacin Impurity 47 Moxifloxacin Impurity 47
Parecoxib sodium Impurity 35 Parecoxib sodium Impurity 35
Tofacitinib Impurity 20 Tofacitinib Impurity 20 1092578-44-3 C27H31N5O2S
Tofacitinib Impurity 88 Tofacitinib Impurity 88
Vildagliptin Impurity ZA9 Vildagliptin Impurity ZA9
Nintedanib Impurity K Nintedanib Impurity K
Tadalafil EP Impurity I Tadalafil EP Impurity I
1,4'-Bipiperidine, 1'-(phenylmethyl)- 1,4'-Bipiperidine, 1'-(phenylmethyl)- 116269-53-5 C17H26N2
[2-(4-Methoxyphenyl)-1-methylethyl]-formamide [2-(4-Methoxyphenyl)-1-methylethyl]-formamide 126002-14-0 C11H15NO2
Indacaterol Impurity 7 Indacaterol Impurity 7 1403389-05-8 C24H30N2O3
tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate 1883672-48-7 C29H38ClN7O4
1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C15H14FNO5
cis-cyclo(Pro-Pro) cis-cyclo(Pro-Pro) 19943-27-2 C10H14N2O2
Ropivacaine-cycle Ropivacaine-cycle 1945965-95-6 C17H24N2O
4-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 4-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 181696-12-8 C16H14N2O3S
Bupivacaine  Impurity Bupivacaine Impurity 2125995-27-7 C18H28N2O.ClH
Brexpiprazole  Impurity Brexpiprazole Impurity 2059954-32-2 C17H21Cl2NO2
BDJS-SH 2 BDJS-SH 2 36585-31-6 C12H18N2O2
Acyclovir Impurity Q Acyclovir Impurity Q
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
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
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
Tofacitinib impurity U Tofacitinib impurity U
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