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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
4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 34523-34-7 C8H9NO2
(S)-Citalopram N-Oxide (S)-Citalopram N-Oxide 917482-45-2 C20H21FN2O2
7-Epi-docetaxel (Docetaxel Impurity C) 7-Epi-docetaxel (Docetaxel Impurity C) 153381-68-1 C43H53NO14
Amido Methyl Meloxicam (Meloxicam Impurity) Amido Methyl Meloxicam (Meloxicam Impurity) 892395-41-4 C15H15N3O4S2
SRI 62320 SRI 62320 94061-80-0 C24H25FNNaO4
Esmolol Impurity 45 Esmolol Impurity 45
Oprinone Impurity 6 Oprinone Impurity 6
lamivudine sulfoxide lamivudine sulfoxide 160552-55-6 C8H11N3O4S
Vitamin B12 e-Monocarboxylic Acid Vitamin B12 e-Monocarboxylic Acid 26264-28-8 C63H87CoN13O15P
caffeidine caffeidine 20041-90-1 C7H12N4O
metreleptin metreleptin 186018-45-1
3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 2055-97-2 C13H6I4O4
Sotalol EP Impurity A Sotalol EP Impurity A 16974-42-8 C12H20N2O2S
digoxigenin-mono(digitoxoside) digoxigenin-mono(digitoxoside) 5352-63-6 C29H44O8
W 36017 W 36017 21236-54-4 C12H18N2O
ONO EI-601 ONO EI-601 155023-59-9 C15H14N2O6S
norchlorpromazine norchlorpromazine 1225-64-5 C16H17ClN2S
ETHYLISOPROPYLNITROSAMINE ETHYLISOPROPYLNITROSAMINE 16339-04-1 C5H12N2O
3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 5409-62-1 C17H20ClNO
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 869884-24-2 C23H26N2O3
Azilsartan Medoxomil Potassium impurity209 Azilsartan Medoxomil Potassium impurity209
Nelarabine impurity 01 Nelarabine impurity 01
Pyridine, 2-(diethylboryl)- (9CI) Pyridine, 2-(diethylboryl)- (9CI) 385804-67-1 C9H14BN
Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) 220353-83-3 C9H10FN
1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 693781-59-8 C31H40O2
Bisoprolol Impurity 50 Bisoprolol Impurity 50
Milnacipran Impurity 26 Milnacipran Impurity 26
Olodaterol Impurity 15 Olodaterol Impurity 15
Dobutamine Impurity 15 Dobutamine Impurity 15
2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 1447814-82-5 C18H16Cl2N2S
Pitavastatin Impurity 104 Pitavastatin Impurity 104
	Olodaterol Impurity 32 Olodaterol Impurity 32
(R)-Lercanidipine Hydrochloride (R)-Lercanidipine Hydrochloride 187731-34-6 C36H42ClN3O6
2-Oxo Clopidogrel Hydrochloride(Mixture of diastereomers) 2-Oxo Clopidogrel Hydrochloride (Mixture of diastereomers) 109904-27-0 C16H16ClNO3S
5-Hydroxy-6-methoxy-1-indanone 5-Hydroxy-6-methoxy-1-indanone 127399-78-4 C10H10O3
Desfluoro Citalopram Oxalate Desfluoro Citalopram Oxalate 1093072-86-6 C22H24N2O5
Didesmethyl Zolmitriptan Didesmethyl Zolmitriptan 139264-15-6 C14H17N3O2
Gabapentin Related Compound E Gabapentin Related Compound E 67950-95-2 C9H14O4
Hydroxy Bosentan Hydroxy Bosentan 253688-60-7 C27H29N5O7S
Lisinopril S,S,S-Diketopiperazine Lisinopril S,S,S-Diketopiperazine 328385-86-0 C21H29N3O4
rac 4-Desmethoxy-4-nitro Omeprazole rac 4-Desmethoxy-4-nitro Omeprazole 317807-10-6 C16H16N4O4S
trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol 201855-60-9 C19H22FNO
ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE 70458-94-5 C14H13ClFNO3
Alvatrombopag Impurity 84 Alvatrombopag Impurity 84
Avatrombopag Impurity 60 Avatrombopag Impurity 60
2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 339114-12-4 C7H5ClN2S2
Capecitabine Related Compound B Capecitabine Related Compound B
D-erythro-3,4-Dihydroxyphenylserine D-erythro-3,4-Dihydroxyphenylserine 51829-98-2 C9H11NO5
aztreonam aztreonam 80951-91-3 C13H17N5O8S2
5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 639857-68-4 C14H13NO
[1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) [1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) 76625-61-1 C12H10O6
Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate 121659-86-7 C20H16FNO2
Silodosin Silodosin 160970-64-9 C25H32F3N3O4
(3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE (3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE 76646-91-8 C8H9Br2NO5S
(E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER (E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER 96914-67-9 C9H13NO2
Nicergoline Impurity 7 Nicergoline Impurity 7
N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine 10563-27-6 C7H18N2O2
4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate 2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate
Tirofiban Impurity 79 Tirofiban Impurity 79 158808-85-6 C21H34N2O5S
Brivaracetam Impurity 47 Brivaracetam Impurity 47 2755924-55-9
(Glu3)-Carbetocin (Impurity D) (Glu3)-Carbetocin (Impurity D)
4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine (Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 94213-23-7 C9H7Cl2N5
Perampanel Impurity ABCDEFGHJKL Perampanel Impurity ABCDEFGHJKL
ethyl 3-acetoxy-2-butenoate ethyl 3-acetoxy-2-butenoate 29214-62-8 C8H12O4
2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 68751-57-5 C11H11BrCl2O3
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2511244-96-3 C27H36N2O6
Oseltamivir  Impurity 91 Oseltamivir Impurity 91
Oseltamivir  Impurity 80 Oseltamivir Impurity 80
Oseltamivir  Impurity 72 Oseltamivir Impurity 72
4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 2512203-87-9 C14H16Br2N2O
Linagliptin impurity KH-3 Linagliptin impurity KH-3 2279114-27-9 C30H37N7O6
11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 3044-42-6 C23H28O5
Ampicillin Impurity U Ampicillin Impurity U
Canagliflozin Hydroperoxide Impurity Canagliflozin Hydroperoxide Impurity
(E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid (E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid 40038-46-8 C13H10N2O3
Sitagliptin EP Impurity 6 Sitagliptin EP Impurity 6
Tegoprazan Impurity 8 Tegoprazan Impurity 8
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2706536-33-4 C27H34N2O2
Nirmatrelvir Impurity 10 Nirmatrelvir Impurity 10
Levosimendan Nitrosogenin Impurities Levosimendan Nitrosogenin Impurities
7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 26973-80-8 C12H13BrN2O6S
Bumetanide Impurity 20 Bumetanide Impurity 20
Rocuronium Bromide Impurity 28 、29 Rocuronium Bromide Impurity 28 、29
Roxadustat Impurity 22 Roxadustat Impurity 22
	Olaparib Impurity 41 Olaparib Impurity 41
Perospirone Impurity 22 Perospirone Impurity 22
Perospirone Impurity 14 Perospirone Impurity 14 87691-94-9 C15H20BrN3S
Dolutegravir Impurity 22 Dolutegravir Impurity 22
Paxlovid Impurity 20 Paxlovid Impurity 20
Related impurities 7 of fluoxetine sodium Related impurities 7 of fluoxetine sodium
Revefenacin Impurity 16 Revefenacin Impurity 16
Fondaparinux sodium impurity 8 Fondaparinux sodium impurity 8
Fondaparinux sodium impurity 14 Fondaparinux sodium impurity 14
Fondaparinux Sodium Impurity 9 Fondaparinux Sodium Impurity 9
Oxacillin sodium  Impurity D Oxacillin sodium Impurity D
Piracetam      IMPURITY Piracetam IMPURITY
Nilotinib N-Oxide Impurity 4 Nilotinib N-Oxide Impurity 4
sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
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